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Safety and Efficacy Study for Solid Tumor Patients Treated With Eltrombopag

A Randomized, Blinded, Placebo-controlled, Two-Phase, Sequential Cohort, Dose Finding Study to Assess the Safety and Efficacy of an Oral Thrombopoietin Receptor Agonist, Eltrombopag (SB-497115-GR), Administered to Patients With Solid Tumors Receiving Gemcitabine Monotherapy or the Combination of Gemcitabine Plus Carboplatin or Cisplatin

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01147809
Enrollment
130
Registered
2010-06-22
Start date
2010-06-30
Completion date
2015-03-31
Last updated
2016-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombocytopaenia

Keywords

Solid Tumor, Eltrombopag, chemotherapy-induced thrombocytopenia, Thrombocytopenia

Brief summary

The present study is a randomized, blinded, placebo-controlled, two-Phase, sequential cohort, dose finding study to assess the safety and efficacy of eltrombopag in patients with solid tumors receiving gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin. Phase I of the study will examine safety and tolerability of various doses of eltrombopag to identify a dose and schedule of eltrombopag. Phase II will confirm that the chosen dose and schedule of eltrombopag from Phase I can deliver clinically meaningful benefit(s) to thrombocytopenic patients by improving platelet numbers.

Interventions

thrombopoietin receptor agonist

OTHERPlacebo

Placebo tablets with no active pharmaceutical ingredient

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion Criteria Subjects eligible for enrolment in Phase I and II of the study must meet all of the following criteria: * Signed written informed consent. * Age ≥ 18 years. * Subjects with confirmed solid tumor and scheduled to receive at least two cycles of either gemcitabine monotherapy OR gemcitabine in combination with carboplatin or cisplatin at the same dosages and schedule in the study. Novel anticancer agents (e.g. bevacizumab, erlotinib) may be allowed if considered a standard treatment by the investigator. Subjects with only ONE current diagnosis of primary solid tumor will be allowed into the study. * Note: For patients scheduled to receive any novel anticancer agents (e.g. bevacizumab, erlotinib), consultation and approval from the GSK medical monitor should occur before the subject is enrolled into the study. * Life expectancy of at least 3 months, in the opinion of the investigator. * ECOG-Zubrod performance status ≤ 2 * For Phase I: Pre-chemotherapy platelet count ≤ 300 Gi/L in the screening period before the subject start their first planned cycle of treatment with gemcitabine monotherapy OR gemcitabine in combination with carboplatin or cisplatin in the study. * For Phase II (Part 1 and 2): Subjects must meet one of the following platelet count entry criteria: 1. Subjects have not started the first cycle in this disease setting and have a platelet count \< 150 Gi/L in the screening period as measured within 3 days before Day -5, OR 2. Subjects started chemotherapy for this disease setting and had platelet count \< 150 Gi/L on Day 1 in the preceding cycle before entry into the study, OR 3. Platelet count \< 100 Gi/L at Day 8 in the preceding cycle before entry into the study, OR 4. Platelet count \< 100 Gi/L at Day 15 in the preceding cycle before entry into the study (for subjects receiving Gemcitabine monotherapy) Note: For any of these platelet counts, a repeated platelet count may be allowed only once to ensure that the subject meets the above platelet count criteria and the latest count will be taken for the assessment of eligibility to the study.. * Subjects with previous chemotherapy treatment in a previous disease setting are allowed provided they have recovered from chemotherapy related toxicity except alopecia (and the lab parameters mentioned in Inclusion criteria in #9). * Adequate organ function during screening period defined by the criteria below (adequate baseline organ function): * SYSTEM LABORATORY VALUES * Hematologic * Platelets, see Inclusion criteria * ANC (absolute neutrophil count) ≥1.5 × 109/L * Hemoglobin ≥9 g/dL * Prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) Within 80 to 120% of the normal range * Hepatic * Albumin ≥2.5 g/dL * Serum bilirubin ≤1.5 x ULN AST and ALT * 3 × ULN without liver metastases * 5 × ULN if documented liver metastases * Renal * Serum Creatinine ≤ 1.2 x ULN * Subjects with AST, ALT or bilirubin values outside the range(s) in the table due to Gilbert's syndrome or asymptomatic gall stones are not excluded. * Women of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to randomization and agree to use effective contraception, during the study and for 4 weeks following the last dose of investigational product. * Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from 2 weeks prior to randomization until 13 weeks after the last dose of study treatment. * Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.

Exclusion criteria

Subjects meeting any of the following criteria must not be enrolled in the study: * Lactating females. * Pre-existing cardiovascular disease (congestive heart failure, New York Heart Association \[NYHA\] Grade III/IV), or arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation), unstable angina, or subjects with a QTc \>450 msec (QTc \>480 msec for subjects with Bundle Branch Block) at study entry, or myocardial infarction within the preceding 6 months. Subjects with a34 pacemaker or defibrillator are not excluded provided that their cardiac function is within normal ranges. * Note: For patients with pre-existing NYHA Grade II cardiovascular disease, the investigator should consult with GSK medical monitor before enrolling the subject into the study. * Patients with known factor V leiden, antiphospholipid antibody syndrome, prothrombin gene mutations, ATIII deficiency, protein C deficiency, protein S deficiency OR recent history of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism) within the preceding 6 months. * Note: for patients with known risk factors for thromboembolism e.g., diabetes, hypercholesterolemia, recent major surgery etc., the investigator should consult with GSK medical monitor before enrolling the patient into the study and all risk factors should be documented in the CRF. * Prior surgery within two weeks before study randomization or radiotherapy (RT) within four weeks before study randomization. Subjects with prior surgery or RT are not permitted into the study unless they have completely recovered from surgery and/or acute RT toxicity except for alopecia. * Note: Note: patients with minor surgeries or outpatient procedures (e.g. insertion of central venous catheter) are immediately allowed in the study provided that there were no complications from the procedure or surgery. * History of prior radiotherapy to more than 20% bone marrow bearing sites. * History of platelet agglutination abnormality, platelet disorders or dysfunction or bleeding disorder that prevents reliable measurement of platelet counts. * Subjects with a history of CNS metastases or clinical signs or symptoms of brain and/or leptomeningeal metastases confirmed by CT or MRI brain scan unless properly treated. Subjects with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to randomization will be excluded. * Treated brain metastases are defined * Having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. * Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Note: if subject has performed a CT scan immediately prior to the screening period and CT could not be repeated, an MRI should be performed in the screening period to exclude the development of brain metastases and/or the progression of the pre-existing brain metastatic lesion(s). * Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of investigational product in the study. Concurrent participation in another interventional clinical trial or administration of any investigational drug during the study is also not permitted. * A known immediate or delayed hypersensitivity reaction or idiosyncrasy that, in the opinion of the Investigator or GSK Medical Monitor is due to drugs chemically related to eltrombopag or excipients (e.g. mannitol). * Subjects with known Hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV). Subjects with Gilbert's Syndrome are permitted into the study.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IFrom Cycle 1, Day 1 (C1D1) until at least 30 days post-investigational product discontinuation (longer for AEs considered related to study participation)AEs are coded using the standard Medical Dictionary for Regulatory Activities (MedDRA) and were graded by the investigator according to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), version 4.0. AE is any untoward medical occurrence temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a MP. For marketed MPs, this also includes failure to produce expected benefits, abuse, or misuse. SAE event is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect.
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IAfter Baseline (C1D1), on-treatment and 30 day follow-upHematology parameters with a related NCI CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment, the maximum toxicity grade reached by a participant post-Baseline was summarized. Hematology parameters included hemoglobin (increased), hemoglobin (anemia), lymphocytes (increased), lymphocytes (decreased), total absolute neutrophil count (ANC), platelets (PLT) and white blood cells (WBC). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. Only those participant available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAfter Baseline (C1D1), on-treatment and 30 day follow-upClinical chemistry laboratory parameters with a related NCI CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment. Clinical chemistry laboratory parameters included albumin (Alb), urea/blood urea nitrogen (BUN), creatinine, aspartate amino transferase (AST), alanine amino transferase (ALT), alkaline phosphatase (ALP), total bilirubin (TB), direct bilirubin (DB) and international normalized ratio/Prothrombin time (PT). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. Only those participants available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).
Number of Participants With a Change From Baseline in Creatinine of >=26.5 Micromoles/Liter (UMOL/L) in Phase IAfter Baseline (C1D1), on-treatment and 30 day follow-upThe number of participants with at least 1 change from Baseline in creatinine, with an increase \>=26.5 UMOL/L are reported. Creatinine clearance is estimated using the Cockcroft-Gault formula which is a method to approximate kidney function. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1.
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IScreening, C1D1, C2D1, C2D8, C2D15, C3D1, C4D1, C4D22, C5D1, C5D8, C6D1, C6D15ECOG-Zubrod scores for the performance status are defined as follows: Score 0: Fully active, 1: restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2: ambulatory and capable of all self-care but unable to carry out any work activities, 3: capable of only limited self-care, 4: completely disabled, 5: dead. The data is presented for the participants with the ECOG performance score at the indicated time points during the study.
Number of Participants With Electrocardiogram (ECG) Findings at Anytime Post-Baseline in Phase IC2D4, C2D8, C5D8, C6D15A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at screening and post-dose on C2D4. Three further ECGs were carried out at C2D8, C5D8 and C6D15. Change in ECG findings were categorized as 'Clinically significant change: favorable', 'No change or insignificant change' or 'Clinically significant change (CSC): unfavorable' as determined by the investigator. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Any time post-Baseline is defined by counting the participants under the worst result experienced post-Baseline. The best to worst order is 'Clinically significant change: favorable', 'No change or insignificant change', and then 'Clinically significant change (CSC): unfavorable. Only those participants available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).
Mean Day 1 Scheduled Pre-chemotherapy Platelet Count Evaluated Across Cycles 1 to 6 in Phase IIDay 1 (averaged across cycles 1 to 6)Scheduled pre-chemotherapy platelet count is defined within each cycle as the platelet count assessment on which the decision to give or delay chemotherapy was made. This was averaged for each participant across Cycles 1 to 6 and a natural log transformation was applied to the average. The log-transformed values were compared between eltrombopag and placebo groups using an analysis of covariance (ANCOVA) model adjusting for cycle duration (21-day vs. 28-day), Baseline loge(platelet count) and part of study (part 1 or 2 of phase II). Only those participants available at indicated time points were analyzed (represented by n=X,X).

Secondary

MeasureTime frameDescription
Central Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase ICycle 1 to Cycle 6Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. The time taken to reach platelet nadir is defined within each cycle. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet nadir count at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsCycle 1 to Cycle 6Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. Time to recovery (TR) (\>100Gi/L or \>150Gi/L) from platelet nadir is defined within each cycle as the time in days from the platelet nadir to the time at which platelet count returns to \>=100Gi/L or \>=150Gi/L within the same cycle or up to and including Day 1 of the next cycle. For the last cycle in the study, time to recovery was calculated in the same manner but up to and including any Conclusion/Early Withdrawal visit which has been assigned to the same cycle. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet count at: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. Group B; Days 1, 4, 8, 15, 22, and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).
Number of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase IAll time on chemotherapy treatmentAny delay in a scheduled dose of gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin was evaluated for eltrombopag and placebo treated participants.
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIFrom first dose of investigational product (IP) until 30 days after discontinuation of IP (Longer for AEs related to study participation)AE is any untoward medical occurrence temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a MP. For marketed MPs, this also includes failure to produce expected benefits, abuse, or misuse. SAE event is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect.
Number of Participants With Any Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale, Across Cycles 1-6 in Phase IIScreening, Day -5, Day 1 and 8 of Cycles 1 to 6 of 21-day cycle schedule, Day 1, 8 and 15 of cycles 1 to 6 of 28-day schedule, treatment withdrawal and 30-day follow-upThe WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0=no bleeding; Grade 1=petechiae; Grade 2=mild blood loss; Grade 3=gross bleeding; Grade 4=debilitating blood loss. The WHO grades were further classified into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. Baseline is defined as the Day 1 assessment or the latest possible screening assessment. Across Cycles 1-6 included all assessments after first dose of chemotherapy up to the end of Cycle 6. Data exclused for participants taking drugs that affect platelet function or anticoagulants, from the time that the medication was started.
Number of Participants Requiring a Platelet Transfusion in Phase IIScreening, Day -5, throughout cycles 1 to 6 and up to 30 days after IP discontinuationPlatelet transfusion was used as a rescue medication for the treatment of thrombocytopenia. Number of participants requiring a platelet transfusion during Cycles 1-6 was summarized and compared between treatment groups using a logistic regression model adjusted for cycle duration. Each cycle included assessments starting at Day 1 of the cycle.
Number of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase IICycle 1 to Cycle 6Any delay in scheduled dose of gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin was evaluated for eltrombopag and placebo treated participants. Number of participants with any delay in dose during 21-day cycle or 28-day cycle, in part 1 or part 2 of the study is summarized and presented. Only those participants who actually received chemotherapy are included for the cisplatin and carboplatin components and all participants are included for the gemcitabine components (represented by n=X,X in the category titles).
Number of Participants With Any Dose Reduction in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase IICycle 1 to Cycle 6Dose reductions are required following potential drug-related toxicities. Number of participants with any dose reduction during 21-day cycle or 28-day cycle, in part 1 or part 2 of the study is summarized and presented. Only participants who actually received chemotherapy were included for the cisplatin and carboplatin components. All participants were included for the gemcitabine components.
Dose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase IICycle 1 to Cycle 6Dose intensity of chemotherapy is defined as the actual dose of chemotherapy given as a percentage of the scheduled C1D1/C1D8 dose, as applicable, within this study: cycle Dose Intensity (%) = Total Actual dose (mg/m\^2) within cycle \*100/ Total Scheduled dose (mg/m\^2) in Cycle 1; wherein Actual Dose (mg/m\^2) = Actual dose (mg)/Body Surface Area reported on eCRF. The average chemotherapy dose intensity at Day 1 across Cycles 1 to 6, Day 8 across Cycles 1 to 6 and Day 15 across Cycles 1 to 6 was summarized and compared between treatment groups using an ANCOVA model adjusted for cycle duration and part of the study.
Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIAfter baseline (C1D1), on-treatment and 30 day follow-upHematology parameters with a related NCI CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment, the maximum toxicity grade reached by a participant post-Baseline was summarized. Hematology parameters included Hemoglobin (Hb) increased, Anemia, Lymphocyte count (Lym), platelet count, White Blood Cell count (WBC) and Total Absolute Neutrophil Count (Total ANC). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. participants with missing Baseline value were assumed to have normal Baseline value. Only those Participant available at the indicated time points were analyzed (represented by n=X,X in the category titles).
Number of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIAfter baseline (C1D1), on-treatment (collected on days 1 and 8 for subjects on 21-day cycle and on days 1, 8 and 15 for subjects on 28-day cycle) and 30 day follow-upClinical chemistry laboratory parameters with a related CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment. Worst-case grade change of the laboratory parameters at anytime post-Baseline is presented as Any grade increase, Increase to Grade 3 or Grade 4. Clinical chemistry laboratory parameters included Albumin (Al), creatinine, AST, ALT, ALP, TB, Calcium hypercalcemia (CaHy)/hypocalcemia (CaHo), Glucose hyperglycemia (GluHy)/hypoglycemia (GluHo), Potassium hypernatremia (KHy)/hyponatremia (KHo) and Sodium hypernatremia (NaHy)/hyponatremia (NaHo). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. Only those Participant available at the indicated time points were analyzed (represented by n=X,X in the category titles).
Average Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1,C4D8, C4D15, C5D1,C5D8, C5D15, C6D1,C6D8 and C6D15Pre-chemotherapy platelet count is defined for Cycle 1 as the platelet count (from central laboratory data) immediately preceding the first dose of chemotherapy within Cycle 1. For all subsequent cycles it is defined as the platelet count (from central laboratory data) immediately preceding, but limited to within 2 days prior to the first dose of chemotherapy at Day 1. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet count at the following time points: Group A; Days 1 and 8 of Cycles 1 to 6. Group B; Days 1, 8 and 15 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).
Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIScreening, C1D1, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1 and C17D1ECOG-Zubrod scores for the Performance Status were defined as follows: 0: Fully active, 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2: Ambulatory and capable of all self-care but unable to carry out any work activities, 3: Capable of only limited self-care, 4: Completely disabled, 5 and Unknown: Dead. The data is presented for the participants with the ECOG performance score at different time points during the study. Only those participants available at the indicated time points were analyzed (represented by n=X,X in the category titles).
Number of Participants With Electrocardiogram (ECG) Findings at Cycle 1 Day 4 (2 to 6 Hours Post-dose) in Phase IIC1D4A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at screening and 2 to 6 hours post-dose on C1D4. Change in ECG findings were categorized as 'Clinically significant change (CSC): favorable', 'No change or insignificant change' or 'Clinically significant change (CSC): unfavorable' as determined by the investigator. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of investigational product. Only those participants available at the indicated time points were analyzed (represented by n=X,X in the category titles).
Mean Day 8 Scheduled Pre-chemotherapy Platelet Counts Evaluated Across Cycles 1 to 6 in Phase IIDay 8 (averaged across cycles 1 to 6)Scheduled pre-chemotherapy platelet count is defined within each cycle as the platelet count assessment on which the decision to give or delay chemotherapy was made. This was averaged for each subject across cycles 1 to 6 and a natural log transformation was applied to the average. The log-transformed values were compared between eltrombopag and placebo groups using an analysis of covariance (ANCOVA) model adjusting for cycle duration (21-day vs. 28-day), baseline loge(platelet count) and part of study (part 1 or 2 of phase II). The number of participants analyzed is the number with a Day 8 scheduled platelet count.
Mean Day 15 Scheduled Pre-chemotherapy Platelet Counts Evaluated Across Cycles 1 to 6 in Phase IIDay 15 (averaged across cycles 1 to 6)Scheduled pre-chemotherapy platelet count is defined within each cycle as the platelet count assessment on which the decision to give or delay chemotherapy was made. This was averaged for each subject across cycles 1 to 6 and a natural log transformation was applied to the average. The log-transformed values were compared between eltrombopag and placebo groups using an analysis of covariance (ANCOVA) model adjusting for cycle duration (21-day vs. 28-day), baseline loge(platelet count) and part of study (part 1 or 2 of phase II). The number of participants analyzed is the number with a Day 15 scheduled platelet count.
Mean Within-subject Platelet Count Prior to Scheduled Chemotherapy Across Cycles 1 to 6 in Phase IIDay 1, Day 8, Day 15 (all averaged across cycles 1 to 6)Within-subject platelet count for each par. was calculated by summing up the visit platelet counts from each of Cycles 1 to 6 and dividing it by the number of cycles in which the par. had data. The average within a treatment group was calculated by summing up the values from each par. within the treatment 21-day cycle dividing it by the number of par. These platelet counts are different from the pre-chemotherapy platelet counts for cycles where the chemotherapy dose was delayed. Average within-subject central laboratory platelet count prior to scheduled chemotherapy across Cycles 1 to 6 are summarized. Blood samples were collected on Day 1 and 8 of Cycles 1 to 6 for 21-day cycle and on Day 1, 8 and 15 from Cycles 1 to 6 for 28-day cycle to estimate the average within subject platelet count prior to scheduled chemotherapy. Only those participants available at the indicated time points were analyzed (represented by n=X,X in the category titles).
Platelet Count Nadir for Each Chemotherapy Cycle in Phase IICycle 1 to Cycle 6Platelet nadir is defined as the lowest platelet count reported after the first dose of chemotherapy within each cycle. Platelet count nadir is defined for each cycle. Blood samples were collected to estimate platelet nadir count at the following time points: 21-day cycle; Day 1, Day 4, Day 8, Day 15 and Day 17 of Cycles 1 to 6. 28-day cycle; Day 1, Day 4, Day 8, Day 15, Day 22, Day 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X).
Average Daily Area Under the Platelet-time Course Across Cycles 1 to 6 in Phase IIAll assessments from Cycle 1 Day 1 to last assessment in Cycle 6The average daily area under the platelet-time course was normalized by dividing the area under curve by total duration. This gives an estimated average platelet value over the time period from cycles 1 to 6. Blood samples were collected to estimate platelet count at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6.
Number of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across Cycles 1 to 6 in Phase IICycle 1 to Cycle 6As per the CTCAE version 4.0, participants with a platelet count \<LLN but \>=75 x 10\^9/L (Gi/L) were considered to have Grade 1 thrombocytopenia; participants with a platelet count \<75Gi/L, but \>=50Gi/L were considered to have Grade 2 thrombocytopenia; participants with a platelet count \<50Gi/L, but \>=25Gi/L were considered to have Grade 3 thrombocytopenia and participants with a platelet count \<25Gi/L were considered to have Grade 4 thrombocytopenia. Blood samples were collected to estimate thrombocytes at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Participants experiencing thrombocytopenia(Platelets \<150Gi/L) at least once within cycle are presented in the category title as n=X,X.
Maximum Duration of Thrombocytopenia Across Cycles 1 to 6 in Phase IICycle 1 to Cycle 6Duration of thrombocytopenia is defined as a period of time in days from the first report of a platelet count with NCI CTCAE Grade 1-4 until the first subsequent report of a platelet count no longer meeting those criteria, regardless of rescue medication usage. It was assessed between Day 1 of Cycle 2 and up to and including any Conclusion/Early Withdrawal visit assigned to the same cycle for participants completing up to 6 cycles, and between Day 1 of Cycle 2 and up to and including the end of Cycle 6 for participants continuing beyond 6 cycles. The chemotherapy cycle for 21-day cycle was 21 days and for 28-day cycle was 28 days. Blood samples were collected to estimate thrombocytes at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 2 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 2 to 6.
Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase IICycle 1 to Cycle 6Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. The time taken to reach platelet nadir is defined within each cycle. Blood samples were collected to estimate platelet nadir count at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X).
Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IICycle 1 to Cycle 6Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. TR (\>100Gi/L or \>150Gi/L) from platelet nadir is defined within each cycle as the time in days from the platelet nadir to the time at which platelet count returns to \>=100Gi/L or \>=150Gi/L within the same cycle or up to and including Day 1 of the next cycle. For the last cycle in the study, time to recovery was calculated in the same manner but up to and including any Conclusion/Early Withdrawal visit which has been assigned to the same cycle. Blood samples were collected to estimate platelet count at: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22, and 24of Cycles 1 to 6. Time to recover censored if platelet count did not return to \>=100/150 Gi/L. Censored results are excluded from calculation of summary statistics. Only those participants available at indicated time points were analyzed (represented by n=X, X).
Number of Participants With Change From Baseline in Creatinine of >=26.5 UMOL/L in Phase IIAfter baseline (C1D1), on-treatment (collected on days 1 and 8 for subjects on 21-day cycle and on days 1, 8 and 15 for subjects on 28-day cycle) and 30 day follow-upNumber of participants with at least 1 assessment of change from Baseline in creatinine, with increase \>=26.5 UMOL/L are presented. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of IP.
Average Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IDay 1 (averaged across Cycles 2 to 6), Day 8 (averaged across Cycles 2 to 6)Within-subject platelet count for each participant was calculated by summing up the visit platelet counts from each of Cycles 1 to 6 and dividing it by the number of cycles in which the participant had data. The average within a treatment group was calculated by summing up the values from each participant within the treatment group and dividing it by the number of participants. These platelet counts are different from the pre-chemotherapy platelet counts for cycles where the chemotherapy dose was delayed. Average within-subject central laboratory platelet count prior to scheduled chemotherapy across Cycles 2 to 6 are summarized. Blood samples were collected on Days 1 and 8 of Cycles 2 to 6 for Group A and on Days 1, 8 and 15 from Cycles 2 to 6 for Group B to estimate the average within subject platelet count prior to scheduled chemotherapy. Only those participants available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).
Platelet Count Nadir for Each Chemotherapy Cycle in Phase ICycle 1 to Cycle 6Platelet nadir is defined as the lowest platelet count (from central laboratory data) reported after the first dose of chemotherapy within each cycle. Platelet count nadir is defined for each cycle. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet nadir count at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 and 2, at Days 1, 4, 8, 15 and 17 of Cycle 3 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).
Central Laboratory Average Daily Area Under the Curve Platelet-time Course Across Cycles 2 to 6 in Phase IAll assessments from Cycle 2 Day 1 to last assessment in Cycle 6The average daily area under the platelet-time course was normalized by dividing the area under curve by total duration. This gives an estimated average platelet value over the time period from cycles 2 to 6. For 21-Day Cycle, the chemotherapy cycle consisted of 21 days and for 28-Day Cycle, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate thrombocytes at the following time points: 21-Day Cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-Day Cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6.
Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase ICycle 1 to Cycle 6Dose intensity of chemotherapy is defined as the actual dose of chemotherapy given as a percentage of the scheduled C1D1/C1D8 dose, as applicable, within this study: Cycle Dose Intensity (%) = Total Actual dose (mg/m\^2) within Cycle \*100/ Total Scheduled dose (mg/m\^2) in Cycle 1; wherein Actual Dose (mg/m\^2) = Actual dose (mg)/Body Surface Area reported on electronic case report form (eCRF).
Number of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet CountCycle 1 to Cycle 6As per the CTCAE version 4.0, par. with a platelet count \<LLN but \>=75 x 10\^9/L (Gi/L) were considered to have Grade 1 thrombocytopenia; par. with a platelet count \<75Gi/L, but \>=50Gi/L were considered to have Grade 2 thrombocytopenia; par. with a platelet count \<50Gi/L, but \>=25Gi/L were considered to have Grade 3 thrombocytopenia and par. with a platelet count \<25Gi/L were considered to have Grade 4 thrombocytopenia. Blood samples were collected to estimate thrombocytes at the following time points: For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate thrombocytes at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Par. experiencing thrombocytopenia (Platelets \<150Gi/L) at least once within a cycle are presented in the category title as n=X,X,X,X.
Maximum Duration of Thrombocytopenia Across Cycles 2 to 6 in Phase I, Estimated Using Central Laboratory Platelet CountsCycle 2 to Cycle 6Duration of thrombocytopenia is defined as a period of time in days from the first report of a platelet count with NCI CTCAE Grade 1-4 until the first subsequent report of a platelet count no longer meeting those criteria, regardless of rescue medication usage. It was assessed between Day 1 of Cycle 2 and up to and including any Conclusion/Early Withdrawal visit assigned to the same cycle for participants completing up to 6 cycles, and between Day 1 of Cycle 2 and up to and including the end of Cycle 6 for participants continuing beyond 6 cycles. The chemotherapy cycle for Group A was 21 days and for Group B was 28 days. Blood samples were collected to estimate thrombocytes at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 2 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 2 to 6.

Countries

Belgium, Canada, Czechia, Finland, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Poland, United States

Participant flow

Recruitment details

Participants (par.) with solid tumors receiving gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin were eligible for enrollment into the study. The study comprised of 2 phases (I & II), with eligible par. being randomized to receive placebo or eltrombopag in each phase.

Pre-assignment details

A total of 108 par. were randomized, of which 101 par. received at least 1 dose of study drug. A maximum of 6 cycles (with some exceptions) of chemotherapy with eltrombopag/placebo were allowed in each phase (either 21-day or 28-day cycle) followed by the 30 day Follow-up visit.

Participants by arm

ArmCount
Phase I: 21-Day Cycle Placebo
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
3
Phase I: 21-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
9
Phase I: 28-Day Cycle Placebo
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
4
Phase I: 28-Day Cycle Eltrombopag 100 mg
Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
10
Phase II: Placebo
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
23
Phase II: Eltrombopag 100 mg
Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
52
Total101

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005
Phase I (168 Days)Adverse Event000100
Phase I (168 Days)Lost to Follow-up100100
Phase I (168 Days)Physician Decision012000
Phase I (168 Days)Withdrawal by Subject000300
Phase II (168 Days)Adverse Event000036
Phase II (168 Days)Ongoing000010
Phase II (168 Days)Physician Decision0000511
Phase II (168 Days)Protocol Violation000001
Phase II (168 Days)Withdrawal by Subject0000715

Baseline characteristics

CharacteristicPhase I: 21-Day Cycle PlaceboPhase I: 21-Day Cycle Eltrombopag 100 mgPhase I: 28-Day Cycle PlaceboPhase I: 28-Day Cycle Eltrombopag 100 mgPhase II: PlaceboPhase II: Eltrombopag 100 mgTotal
Age, Continuous53.3 Years
STANDARD_DEVIATION 3.79
53.8 Years
STANDARD_DEVIATION 11.27
61.8 Years
STANDARD_DEVIATION 22.82
65.6 Years
STANDARD_DEVIATION 8.41
64.4 Years
STANDARD_DEVIATION 9.96
66.3 Years
STANDARD_DEVIATION 8.98
64.1 Years
STANDARD_DEVIATION 10.56
Race/Ethnicity, Customized
African American/African Heritage
1 Participants1 Participants0 Participants0 Participants1 Participants0 Participants3 Participants
Race/Ethnicity, Customized
Central/South Asian Heritage
0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Japanese/East Asian Heritage/South East Asian
0 Participants0 Participants0 Participants2 Participants0 Participants0 Participants2 Participants
Race/Ethnicity, Customized
White
2 Participants8 Participants3 Participants8 Participants22 Participants52 Participants95 Participants
Sex: Female, Male
Female
1 Participants7 Participants3 Participants3 Participants13 Participants23 Participants50 Participants
Sex: Female, Male
Male
2 Participants2 Participants1 Participants7 Participants10 Participants29 Participants51 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —— / —
other
Total, other adverse events
3 / 39 / 94 / 410 / 1022 / 2347 / 52
serious
Total, serious adverse events
1 / 35 / 91 / 42 / 1013 / 2317 / 52

Outcome results

Primary

Mean Day 1 Scheduled Pre-chemotherapy Platelet Count Evaluated Across Cycles 1 to 6 in Phase II

Scheduled pre-chemotherapy platelet count is defined within each cycle as the platelet count assessment on which the decision to give or delay chemotherapy was made. This was averaged for each participant across Cycles 1 to 6 and a natural log transformation was applied to the average. The log-transformed values were compared between eltrombopag and placebo groups using an analysis of covariance (ANCOVA) model adjusting for cycle duration (21-day vs. 28-day), Baseline loge(platelet count) and part of study (part 1 or 2 of phase II). Only those participants available at indicated time points were analyzed (represented by n=X,X).

Time frame: Day 1 (averaged across cycles 1 to 6)

Population: Intent-to Treat (ITT) Population: all randomized participants.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
21-Day Cycle PlaceboMean Day 1 Scheduled Pre-chemotherapy Platelet Count Evaluated Across Cycles 1 to 6 in Phase II193.34 Giga (10^9) cells per liter (Gi/L)Geometric Coefficient of Variation 54.5
21-Day Cycle Eltrombopag 100 mgMean Day 1 Scheduled Pre-chemotherapy Platelet Count Evaluated Across Cycles 1 to 6 in Phase II246.20 Giga (10^9) cells per liter (Gi/L)Geometric Coefficient of Variation 49.8
p-value: 0.10395% CI: [-3.9, 52.5]ANCOVA
Primary

Number of Participants With a Change From Baseline in Creatinine of >=26.5 Micromoles/Liter (UMOL/L) in Phase I

The number of participants with at least 1 change from Baseline in creatinine, with an increase \>=26.5 UMOL/L are reported. Creatinine clearance is estimated using the Cockcroft-Gault formula which is a method to approximate kidney function. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1.

Time frame: After Baseline (C1D1), on-treatment and 30 day follow-up

Population: Safety Population

ArmMeasureValue (NUMBER)
21-Day Cycle PlaceboNumber of Participants With a Change From Baseline in Creatinine of >=26.5 Micromoles/Liter (UMOL/L) in Phase I0 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With a Change From Baseline in Creatinine of >=26.5 Micromoles/Liter (UMOL/L) in Phase I3 Participants
28-Day Cycle PlaceboNumber of Participants With a Change From Baseline in Creatinine of >=26.5 Micromoles/Liter (UMOL/L) in Phase I1 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With a Change From Baseline in Creatinine of >=26.5 Micromoles/Liter (UMOL/L) in Phase I2 Participants
Primary

Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase I

AEs are coded using the standard Medical Dictionary for Regulatory Activities (MedDRA) and were graded by the investigator according to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), version 4.0. AE is any untoward medical occurrence temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a MP. For marketed MPs, this also includes failure to produce expected benefits, abuse, or misuse. SAE event is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect.

Time frame: From Cycle 1, Day 1 (C1D1) until at least 30 days post-investigational product discontinuation (longer for AEs considered related to study participation)

Population: Safety Population

ArmMeasureGroupValue (NUMBER)
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IRenal AEs On-therapy+30 days0 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase ILiver AEs On-therapy+30 days0 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAny SAE Post-therapy0 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IPlatelet count increased On-therapy+30 days0 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase I>=Grade 3 AEs On-therapy+30 days2 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase ITreatment-related AEs On-therapy+30 days2 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase ILeukopenia On-therapy+30 days1 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IThrombocytopenia On-therapy+30 days2 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAny AE On-therapy+30 days3 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAny AE Pre-therapy3 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAnemia On-therapy+30 days1 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase INeutropenia On-therapy+30 days3 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAny SAE On-therapy+30 days1 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IThrombocytosis On-therapy+30 days2 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase ICardiac AEs On-therapy+30 days0 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IThromboembolic events On-therapy+30 days0 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAny AE Post-therapy0 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAny SAE Pre-therapy1 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAny AE On-therapy+30 days9 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAny AE Pre-therapy8 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAny SAE Pre-therapy0 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAny SAE On-therapy+30 days5 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAny AE Post-therapy0 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAny SAE Post-therapy0 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase ITreatment-related AEs On-therapy+30 days3 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase I>=Grade 3 AEs On-therapy+30 days7 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase ILiver AEs On-therapy+30 days2 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IRenal AEs On-therapy+30 days3 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IThromboembolic events On-therapy+30 days2 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase ICardiac AEs On-therapy+30 days1 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase INeutropenia On-therapy+30 days4 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAnemia On-therapy+30 days4 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IThrombocytopenia On-therapy+30 days3 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase ILeukopenia On-therapy+30 days2 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IThrombocytosis On-therapy+30 days2 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IPlatelet count increased On-therapy+30 days0 Participants
28-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAny AE Post-therapy0 Participants
28-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IRenal AEs On-therapy+30 days2 Participants
28-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IThromboembolic events On-therapy+30 days0 Participants
28-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAny SAE On-therapy+30 days1 Participants
28-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IPlatelet count increased On-therapy+30 days0 Participants
28-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase ICardiac AEs On-therapy+30 days1 Participants
28-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IThrombocytosis On-therapy+30 days1 Participants
28-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase INeutropenia On-therapy+30 days2 Participants
28-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAny AE On-therapy+30 days3 Participants
28-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAnemia On-therapy+30 days1 Participants
28-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAny AE Pre-therapy4 Participants
28-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IThrombocytopenia On-therapy+30 days3 Participants
28-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAny SAE Pre-therapy0 Participants
28-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase ITreatment-related AEs On-therapy+30 days1 Participants
28-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAny SAE Post-therapy0 Participants
28-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase I>=Grade 3 AEs On-therapy+30 days2 Participants
28-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase ILeukopenia On-therapy+30 days2 Participants
28-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase ILiver AEs On-therapy+30 days0 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase ITreatment-related AEs On-therapy+30 days6 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase ILeukopenia On-therapy+30 days3 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAnemia On-therapy+30 days4 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IRenal AEs On-therapy+30 days0 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAny SAE On-therapy+30 days2 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAny AE Pre-therapy9 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAny SAE Pre-therapy1 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IThromboembolic events On-therapy+30 days1 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAny AE Post-therapy3 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IPlatelet count increased On-therapy+30 days3 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IThrombocytopenia On-therapy+30 days3 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase ICardiac AEs On-therapy+30 days1 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAny AE On-therapy+30 days10 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IAny SAE Post-therapy1 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase ILiver AEs On-therapy+30 days2 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase INeutropenia On-therapy+30 days5 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase I>=Grade 3 AEs On-therapy+30 days3 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IThrombocytosis On-therapy+30 days2 Participants
Primary

Number of Participants With Electrocardiogram (ECG) Findings at Anytime Post-Baseline in Phase I

A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at screening and post-dose on C2D4. Three further ECGs were carried out at C2D8, C5D8 and C6D15. Change in ECG findings were categorized as 'Clinically significant change: favorable', 'No change or insignificant change' or 'Clinically significant change (CSC): unfavorable' as determined by the investigator. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Any time post-Baseline is defined by counting the participants under the worst result experienced post-Baseline. The best to worst order is 'Clinically significant change: favorable', 'No change or insignificant change', and then 'Clinically significant change (CSC): unfavorable. Only those participants available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).

Time frame: C2D4, C2D8, C5D8, C6D15

Population: Safety Population

ArmMeasureGroupValue (NUMBER)
21-Day Cycle PlaceboNumber of Participants With Electrocardiogram (ECG) Findings at Anytime Post-Baseline in Phase INo change or insignificant change n=3,9,3,83 Participants
21-Day Cycle PlaceboNumber of Participants With Electrocardiogram (ECG) Findings at Anytime Post-Baseline in Phase ICSC: unfavorable, n=3,9,3,80 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Electrocardiogram (ECG) Findings at Anytime Post-Baseline in Phase ICSC: unfavorable, n=3,9,3,81 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Electrocardiogram (ECG) Findings at Anytime Post-Baseline in Phase INo change or insignificant change n=3,9,3,88 Participants
28-Day Cycle PlaceboNumber of Participants With Electrocardiogram (ECG) Findings at Anytime Post-Baseline in Phase INo change or insignificant change n=3,9,3,83 Participants
28-Day Cycle PlaceboNumber of Participants With Electrocardiogram (ECG) Findings at Anytime Post-Baseline in Phase ICSC: unfavorable, n=3,9,3,80 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Electrocardiogram (ECG) Findings at Anytime Post-Baseline in Phase INo change or insignificant change n=3,9,3,87 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Electrocardiogram (ECG) Findings at Anytime Post-Baseline in Phase ICSC: unfavorable, n=3,9,3,81 Participants
Primary

Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I

Clinical chemistry laboratory parameters with a related NCI CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment. Clinical chemistry laboratory parameters included albumin (Alb), urea/blood urea nitrogen (BUN), creatinine, aspartate amino transferase (AST), alanine amino transferase (ALT), alkaline phosphatase (ALP), total bilirubin (TB), direct bilirubin (DB) and international normalized ratio/Prothrombin time (PT). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. Only those participants available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).

Time frame: After Baseline (C1D1), on-treatment and 30 day follow-up

Population: Safety Population

ArmMeasureGroupValue (NUMBER)
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAST, Grade 2, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAlb, Grade 1, n=3,9,4,101 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAlb, Grade 2, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAlb, Grade 3, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALP, Grade 0, n=3,9,4,102 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALP, Grade 1, n=3,9,4,101 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALP, Grade 2, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALP, Grade 3, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALT, Grade 0, n=3,9,4,102 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALT, Grade 1, n=3,9,4,101 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALT, Grade 2, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALT, Grade 3, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAST, Grade 0, n=3,9,4,102 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAST, Grade 1, n=3,9,4,101 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAlb, Grade 0, n=3,9,4,102 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAST, Grade 3, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ITB, Grade 0, n=3,9,4,103 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ITB, Grade 1, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ITB, Grade 2, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ITB, Grade 3, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypercalcemia), Grade 0, n=3,9,4,103 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypercalcemia), Grade 1, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypercalcemia), Grade 2, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypercalcemia), Grade 3, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypocalcemia), Grade 0, n=3,9,4,102 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypocalcemia), Grade 1, n=3,9,4,101 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypocalcemia), Grade 2, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypocalcemia), Grade 3, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICreatinine, Grade 0, n=3,9,4,103 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICreatinine, Grade 1, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICreatinine, Grade 2, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICreatinine, Grade 3, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hyperglycemia), Grade 0, n=3,9,4,102 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hyperglycemia), Grade 1, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hyperglycemia), Grade 2, n=3,9,4,101 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hyperglycemia), Grade 3, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hypoglycemia), Grade 0, n=3,9,4,103 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hypoglycemia), Grade 1, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hypoglycemia), Grade 2, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hypoglycemia), Grade 3, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hyperkalemia), Grade 0, n=3,9,4,101 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hyperkalemia), Grade 1, n=3,9,4,102 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hyperkalemia), Grade 2, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hyperkalemia), Grade 3, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hypokalemia), Grade 0, n=3,9,4,102 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hypokalemia), Grade 1, n=3,9,4,101 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hypokalemia), Grade 2, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hypokalemia), Grade 3, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hypernatremia), Grade 0, n=3,9,4,102 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hypernatremia), Grade 1, n=3,9,4,101 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hypernatremia), Grade 2, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hypernatremia), Grade 3, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hyponatremia), Grade 0, n=3,9,4,102 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hyponatremia), Grade 1, n=3,9,4,101 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hyponatremia), Grade 2, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hyponatremia), Grade 3, n=3,9,4,100 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hyponatremia), Grade 2, n=3,9,4,100 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICreatinine, Grade 0, n=3,9,4,107 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALT, Grade 1, n=3,9,4,104 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAlb, Grade 0, n=3,9,4,104 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hypernatremia), Grade 1, n=3,9,4,100 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICreatinine, Grade 1, n=3,9,4,101 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ITB, Grade 3, n=3,9,4,100 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hyperkalemia), Grade 1, n=3,9,4,101 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAST, Grade 1, n=3,9,4,103 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICreatinine, Grade 2, n=3,9,4,101 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hypokalemia), Grade 0, n=3,9,4,105 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hyponatremia), Grade 0, n=3,9,4,104 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hyperkalemia), Grade 0, n=3,9,4,108 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICreatinine, Grade 3, n=3,9,4,100 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALT, Grade 0, n=3,9,4,103 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hypoglycemia), Grade 3, n=3,9,4,100 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypercalcemia), Grade 0, n=3,9,4,108 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hyperglycemia), Grade 0, n=3,9,4,103 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ITB, Grade 0, n=3,9,4,105 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hypoglycemia), Grade 2, n=3,9,4,101 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hypernatremia), Grade 2, n=3,9,4,100 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hyperglycemia), Grade 1, n=3,9,4,104 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hyponatremia), Grade 3, n=3,9,4,101 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hypoglycemia), Grade 1, n=3,9,4,100 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hypokalemia), Grade 3, n=3,9,4,101 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hyperglycemia), Grade 2, n=3,9,4,102 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypercalcemia), Grade 1, n=3,9,4,101 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hypernatremia), Grade 3, n=3,9,4,100 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hypoglycemia), Grade 0, n=3,9,4,108 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hyperglycemia), Grade 3, n=3,9,4,100 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hypokalemia), Grade 1, n=3,9,4,103 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALP, Grade 3, n=3,9,4,100 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hyponatremia), Grade 1, n=3,9,4,104 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypercalcemia), Grade 2, n=3,9,4,100 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hypokalemia), Grade 2, n=3,9,4,100 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALP, Grade 2, n=3,9,4,101 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALP, Grade 1, n=3,9,4,105 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypercalcemia), Grade 3, n=3,9,4,100 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ITB, Grade 1, n=3,9,4,102 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hyperkalemia), Grade 3, n=3,9,4,100 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAST, Grade 3, n=3,9,4,101 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypocalcemia), Grade 0, n=3,9,4,107 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALT, Grade 3, n=3,9,4,100 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALP, Grade 0, n=3,9,4,103 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hypernatremia), Grade 0, n=3,9,4,109 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypocalcemia), Grade 1, n=3,9,4,101 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAST, Grade 2, n=3,9,4,101 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAlb, Grade 3, n=3,9,4,100 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ITB, Grade 2, n=3,9,4,102 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypocalcemia), Grade 2, n=3,9,4,101 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAST, Grade 0, n=3,9,4,104 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAlb, Grade 2, n=3,9,4,103 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAlb, Grade 1, n=3,9,4,102 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypocalcemia), Grade 3, n=3,9,4,100 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALT, Grade 2, n=3,9,4,102 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hyperkalemia), Grade 2, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypocalcemia), Grade 0, n=3,9,4,103 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAST, Grade 2, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAST, Grade 3, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hyponatremia), Grade 1, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ITB, Grade 0, n=3,9,4,103 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ITB, Grade 1, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hypokalemia), Grade 2, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ITB, Grade 2, n=3,9,4,101 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ITB, Grade 3, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypercalcemia), Grade 0, n=3,9,4,104 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypercalcemia), Grade 1, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hypokalemia), Grade 3, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypercalcemia), Grade 2, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypercalcemia), Grade 3, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hyponatremia), Grade 3, n=3,9,4,102 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hypokalemia), Grade 1, n=3,9,4,101 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypocalcemia), Grade 1, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hypernatremia), Grade 0, n=3,9,4,103 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypocalcemia), Grade 2, n=3,9,4,101 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypocalcemia), Grade 3, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICreatinine, Grade 0, n=3,9,4,104 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICreatinine, Grade 1, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hypernatremia), Grade 1, n=3,9,4,101 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICreatinine, Grade 2, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICreatinine, Grade 3, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hyponatremia), Grade 2, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hyperglycemia), Grade 0, n=3,9,4,101 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hyperglycemia), Grade 1, n=3,9,4,102 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hypernatremia), Grade 2, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hyperglycemia), Grade 2, n=3,9,4,101 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hyperglycemia), Grade 3, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hypoglycemia), Grade 0, n=3,9,4,104 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hypoglycemia), Grade 1, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hypernatremia), Grade 3, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hypoglycemia), Grade 2, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hypoglycemia), Grade 3, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hyperkalemia), Grade 0, n=3,9,4,103 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hyperkalemia), Grade 1, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hyponatremia), Grade 0, n=3,9,4,102 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAlb, Grade 0, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAlb, Grade 1, n=3,9,4,102 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hyperkalemia), Grade 2, n=3,9,4,101 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAlb, Grade 2, n=3,9,4,101 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAlb, Grade 3, n=3,9,4,101 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALP, Grade 0, n=3,9,4,103 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALP, Grade 1, n=3,9,4,101 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hyperkalemia), Grade 3, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALP, Grade 2, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALP, Grade 3, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALT, Grade 0, n=3,9,4,103 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALT, Grade 1, n=3,9,4,101 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hypokalemia), Grade 0, n=3,9,4,103 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALT, Grade 2, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALT, Grade 3, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAST, Grade 0, n=3,9,4,102 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAST, Grade 1, n=3,9,4,102 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAST, Grade 1, n=3,9,4,103 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICreatinine, Grade 0, n=3,9,4,109 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALT, Grade 1, n=3,9,4,105 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAlb, Grade 0, n=3,9,4,104 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypocalcemia), Grade 3, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hypernatremia), Grade 0, n=3,9,4,1010 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAST, Grade 0, n=3,9,4,105 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAlb, Grade 1, n=3,9,4,105 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ITB, Grade 2, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypocalcemia), Grade 2, n=3,9,4,101 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hypokalemia), Grade 1, n=3,9,4,103 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAlb, Grade 2, n=3,9,4,101 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hyperkalemia), Grade 2, n=3,9,4,101 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypocalcemia), Grade 1, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALT, Grade 2, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAlb, Grade 3, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hyponatremia), Grade 0, n=3,9,4,105 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypocalcemia), Grade 0, n=3,9,4,109 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hypokalemia), Grade 0, n=3,9,4,107 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALP, Grade 0, n=3,9,4,106 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypercalcemia), Grade 3, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hypokalemia), Grade 3, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ITB, Grade 1, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALP, Grade 1, n=3,9,4,101 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAST, Grade 2, n=3,9,4,101 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypercalcemia), Grade 2, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALT, Grade 3, n=3,9,4,101 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALP, Grade 2, n=3,9,4,102 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hyperkalemia), Grade 3, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypercalcemia), Grade 1, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ITB, Grade 0, n=3,9,4,108 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hyperglycemia), Grade 3, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hyponatremia), Grade 2, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hypernatremia), Grade 2, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALP, Grade 3, n=3,9,4,101 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hypoglycemia), Grade 0, n=3,9,4,108 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hyperglycemia), Grade 2, n=3,9,4,104 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hyperglycemia), Grade 1, n=3,9,4,104 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICa (hypercalcemia), Grade 0, n=3,9,4,1010 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hypoglycemia), Grade 1, n=3,9,4,101 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hyponatremia), Grade 1, n=3,9,4,105 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hyperglycemia), Grade 0, n=3,9,4,102 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IAST, Grade 3, n=3,9,4,101 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hypoglycemia), Grade 2, n=3,9,4,101 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hypernatremia), Grade 3, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICreatinine, Grade 3, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IALT, Grade 0, n=3,9,4,104 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IGlu (hypoglycemia), Grade 3, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hyponatremia), Grade 3, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase INa (hypernatremia), Grade 1, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ITB, Grade 3, n=3,9,4,102 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hyperkalemia), Grade 0, n=3,9,4,109 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICreatinine, Grade 2, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase ICreatinine, Grade 1, n=3,9,4,101 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hypokalemia), Grade 2, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase IK (hyperkalemia), Grade 1, n=3,9,4,100 Participants
Primary

Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I

Hematology parameters with a related NCI CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment, the maximum toxicity grade reached by a participant post-Baseline was summarized. Hematology parameters included hemoglobin (increased), hemoglobin (anemia), lymphocytes (increased), lymphocytes (decreased), total absolute neutrophil count (ANC), platelets (PLT) and white blood cells (WBC). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. Only those participant available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).

Time frame: After Baseline (C1D1), on-treatment and 30 day follow-up

Population: Safety Population

ArmMeasureGroupValue (NUMBER)
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IHemoglobin (Increased), Grade 0, n=3,9,4,103 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IPLT, Grade 4, n=3,9,4,102 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ITotal ANC, Grade 1, n=1,2,1,21 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IHemoglobin (Anemia), Grade 3, n=3,9,4,101 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IPLT, Grade 0, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IPLT, Grade 3, n=3,9,4,101 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IPLT, Grade 1, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IHemoglobin (Anemia), Grade 1, n=3,9,4,102 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IPLT, Grade 2, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IWBC, Grade 3, n=3,9,4,101 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Increased), Grade 0, n=3,9,4,103 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Increased), Grade 2, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IWBC, Grade 2, n=3,9,4,102 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Decreased), Grade 0, n=3,9,4,101 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IWBC, Grade 4, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Decreased), Grade 1, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IHemoglobin (Anemia), Grade 2, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IWBC, Grade 1, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Decreased), Grade 2, n=3,9,4,101 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Decreased), Grade 3, n=3,9,4,101 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IWBC, Grade 0, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Decreased), Grade 4, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ITotal ANC, Grade 0, n=1,2,1,20 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IWBC, Grade 0, n=3,9,4,100 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IWBC, Grade 3, n=3,9,4,105 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Decreased), Grade 0, n=3,9,4,101 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ITotal ANC, Grade 1, n=1,2,1,20 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Decreased), Grade 3, n=3,9,4,105 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IPLT, Grade 3, n=3,9,4,102 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IWBC, Grade 1, n=3,9,4,101 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IPLT, Grade 0, n=3,9,4,101 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IHemoglobin (Anemia), Grade 3, n=3,9,4,102 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IWBC, Grade 4, n=3,9,4,101 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Decreased), Grade 1, n=3,9,4,102 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IPLT, Grade 1, n=3,9,4,101 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IPLT, Grade 4, n=3,9,4,102 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IPLT, Grade 2, n=3,9,4,103 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ITotal ANC, Grade 0, n=1,2,1,22 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Decreased), Grade 4, n=3,9,4,100 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Decreased), Grade 2, n=3,9,4,101 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Increased), Grade 0, n=3,9,4,108 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IHemoglobin (Anemia), Grade 1, n=3,9,4,101 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IWBC, Grade 2, n=3,9,4,102 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IHemoglobin (Anemia), Grade 2, n=3,9,4,106 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Increased), Grade 2, n=3,9,4,101 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IHemoglobin (Increased), Grade 0, n=3,9,4,109 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ITotal ANC, Grade 0, n=1,2,1,21 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IHemoglobin (Increased), Grade 0, n=3,9,4,104 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IHemoglobin (Anemia), Grade 1, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IHemoglobin (Anemia), Grade 2, n=3,9,4,102 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IHemoglobin (Anemia), Grade 3, n=3,9,4,102 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Increased), Grade 0, n=3,9,4,104 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Increased), Grade 2, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Decreased), Grade 0, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Decreased), Grade 1, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Decreased), Grade 2, n=3,9,4,101 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Decreased), Grade 3, n=3,9,4,103 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Decreased), Grade 4, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ITotal ANC, Grade 1, n=1,2,1,20 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IPLT, Grade 0, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IPLT, Grade 1, n=3,9,4,101 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IPLT, Grade 2, n=3,9,4,101 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IPLT, Grade 3, n=3,9,4,102 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IPLT, Grade 4, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IWBC, Grade 0, n=3,9,4,101 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IWBC, Grade 1, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IWBC, Grade 2, n=3,9,4,101 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IWBC, Grade 3, n=3,9,4,102 Participants
28-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IWBC, Grade 4, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Decreased), Grade 4, n=3,9,4,101 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IWBC, Grade 4, n=3,9,4,101 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IPLT, Grade 4, n=3,9,4,101 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Decreased), Grade 3, n=3,9,4,102 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Decreased), Grade 2, n=3,9,4,104 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IWBC, Grade 3, n=3,9,4,103 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IWBC, Grade 0, n=3,9,4,102 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Decreased), Grade 1, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Decreased), Grade 0, n=3,9,4,103 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IHemoglobin (Anemia), Grade 1, n=3,9,4,103 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IWBC, Grade 1, n=3,9,4,102 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Increased), Grade 2, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ILymphocytes (Increased), Grade 0, n=3,9,4,1010 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IHemoglobin (Increased), Grade 0, n=3,9,4,1010 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IWBC, Grade 2, n=3,9,4,102 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IPLT, Grade 1, n=3,9,4,103 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IHemoglobin (Anemia), Grade 3, n=3,9,4,103 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IPLT, Grade 2, n=3,9,4,103 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IPLT, Grade 0, n=3,9,4,102 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ITotal ANC, Grade 1, n=1,2,1,22 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IHemoglobin (Anemia), Grade 2, n=3,9,4,104 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IPLT, Grade 3, n=3,9,4,101 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase ITotal ANC, Grade 0, n=1,2,1,20 Participants
Primary

Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I

ECOG-Zubrod scores for the performance status are defined as follows: Score 0: Fully active, 1: restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2: ambulatory and capable of all self-care but unable to carry out any work activities, 3: capable of only limited self-care, 4: completely disabled, 5: dead. The data is presented for the participants with the ECOG performance score at the indicated time points during the study.

Time frame: Screening, C1D1, C2D1, C2D8, C2D15, C3D1, C4D1, C4D22, C5D1, C5D8, C6D1, C6D15

Population: Safety Population

ArmMeasureGroupValue (NUMBER)
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D1, Score 0, n=1,1,1,40 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D8, Score 0, n=1,0,1,01 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D8, Score 0, n=0,1,0,0NA Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D22, Score 2, n=0,0,0,1NA Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IScreening, Score 3, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D8, Score 1, n=1,0,1,00 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D1, Score 0, n=2,6,1,71 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D15, Score 2, n=0,0,0,1NA Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D1, Score 3, n=2,6,1,70 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D8, Score 2, n=1,0,1,00 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D22, Score 3, n=0,0,0,1NA Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D15, Score 0, n=0,0,0,1NA Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D1, Score 1, n=1,1,1,41 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D8, Score 3, n=1,0,1,01 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D15, Score 1, n=0,0,0,1NA Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC1D1, Score 2, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IScreening, Score 0, n=3,9,4,103 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D15, Score 0, n=0,1,0,1NA Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D1, Score 0, n=1,3,1,40 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D22, Score 0, n=0,0,0,1NA Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC1D1, Score 0, n=3,9,4,103 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D15, Score 1, n=0,1,0,1NA Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D1, Score 2, n=2,6,1,70 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D1, Score 2, n=3,8,4,101 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D8, Score 3, n=0,1,0,0NA Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D15, Score 2, n=0,1,0,1NA Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D1, Score 1, n=1,3,1,41 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D1, Score 2, n=1,1,1,40 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC1D1, Score 3, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D15, Score 3, n=0,1,0,1NA Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D15, Score 3, n=0,0,0,1NA Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D1, Score 1, n=3,8,4,101 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IScreening, Score 1, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC3D1, Score 0, n=2,6,2,71 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D1, Score 0, n=3,8,4,101 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D1, Score 2, n=1,3,1,40 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC1D1, Score 1, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC3D1, Score 1, n=2,6,2,71 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D22, Score 1, n=0,0,0,1NA Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D1, Score 3, n=1,1,1,40 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IScreening, Score 2, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC3D1, Score 2, n=2,6,2,70 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D1, Score 1, n=2,6,1,71 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D1, Score 3, n=1,3,1,40 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D8, Score 2, n=0,1,0,0NA Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC3D1, Score 3, n=2,6,2,70 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D1, Score 3, n=3,8,4,100 Participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D8, Score 1, n=0,1,0,0NA Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D8, Score 2, n=0,1,0,00 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D1, Score 0, n=2,6,1,71 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D1, Score 1, n=2,6,1,73 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D15, Score 0, n=0,0,0,1NA Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC1D1, Score 2, n=3,9,4,101 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D1, Score 2, n=2,6,1,71 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D1, Score 1, n=3,8,4,104 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D1, Score 3, n=2,6,1,71 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D15, Score 1, n=0,0,0,1NA Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D22, Score 0, n=0,0,0,1NA Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D22, Score 1, n=0,0,0,1NA Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D15, Score 3, n=0,0,0,1NA Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D22, Score 2, n=0,0,0,1NA Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC1D1, Score 3, n=3,9,4,100 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D22, Score 3, n=0,0,0,1NA Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D15, Score 2, n=0,0,0,1NA Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D8, Score 3, n=0,1,0,01 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D1, Score 0, n=1,3,1,40 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D1, Score 3, n=3,8,4,100 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IScreening, Score 0, n=3,9,4,105 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D1, Score 1, n=1,3,1,41 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D1, Score 2, n=1,3,1,41 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D1, Score 0, n=3,8,4,103 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D1, Score 3, n=1,3,1,41 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D8, Score 0, n=1,0,1,0NA Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D1, Score 0, n=1,1,1,41 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D8, Score 1, n=1,0,1,0NA Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D8, Score 1, n=0,1,0,00 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IScreening, Score 3, n=3,9,4,100 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D8, Score 2, n=1,0,1,0NA Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IScreening, Score 2, n=3,9,4,101 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D8, Score 3, n=1,0,1,0NA Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D1, Score 1, n=1,1,1,40 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D15, Score 0, n=0,1,0,10 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D8, Score 0, n=0,1,0,00 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D15, Score 1, n=0,1,0,10 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC1D1, Score 0, n=3,9,4,105 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D15, Score 2, n=0,1,0,11 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D1, Score 2, n=1,1,1,40 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D15, Score 3, n=0,1,0,10 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC3D1, Score 0, n=2,6,2,72 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D1, Score 2, n=3,8,4,101 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC3D1, Score 1, n=2,6,2,72 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC1D1, Score 1, n=3,9,4,103 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC3D1, Score 2, n=2,6,2,71 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D1, Score 3, n=1,1,1,40 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC3D1, Score 3, n=2,6,2,71 Participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IScreening, Score 1, n=3,9,4,103 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D1, Score 3, n=1,3,1,40 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D8, Score 0, n=0,1,0,0NA Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D8, Score 1, n=0,1,0,0NA Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D8, Score 2, n=0,1,0,0NA Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D8, Score 3, n=0,1,0,0NA Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D1, Score 1, n=3,8,4,101 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D1, Score 0, n=1,1,1,40 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D1, Score 1, n=1,1,1,41 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D1, Score 2, n=1,1,1,40 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D1, Score 3, n=1,1,1,40 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D1, Score 2, n=3,8,4,101 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D15, Score 0, n=0,0,0,1NA Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IScreening, Score 2, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D15, Score 1, n=0,0,0,1NA Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D15, Score 2, n=0,0,0,1NA Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D15, Score 3, n=0,0,0,1NA Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D1, Score 3, n=3,8,4,100 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IScreening, Score 0, n=3,9,4,101 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D8, Score 0, n=1,0,1,00 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D8, Score 1, n=1,0,1,00 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D8, Score 2, n=1,0,1,01 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IScreening, Score 3, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D8, Score 3, n=1,0,1,00 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D15, Score 0, n=0,1,0,1NA Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D15, Score 1, n=0,1,0,1NA Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D15, Score 2, n=0,1,0,1NA Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC1D1, Score 0, n=3,9,4,102 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D15, Score 3, n=0,1,0,1NA Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC3D1, Score 0, n=2,6,2,72 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC3D1, Score 1, n=2,6,2,70 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC3D1, Score 2, n=2,6,2,70 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC1D1, Score 1, n=3,9,4,102 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC3D1, Score 3, n=2,6,2,70 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D1, Score 0, n=2,6,1,70 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D1, Score 1, n=2,6,1,71 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D1, Score 2, n=2,6,1,70 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC1D1, Score 2, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D1, Score 3, n=2,6,1,70 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IScreening, Score 1, n=3,9,4,103 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D22, Score 0, n=0,0,0,1NA Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D22, Score 1, n=0,0,0,1NA Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D22, Score 2, n=0,0,0,1NA Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D22, Score 3, n=0,0,0,1NA Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC1D1, Score 3, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D1, Score 0, n=1,3,1,40 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D1, Score 1, n=1,3,1,41 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D1, Score 2, n=1,3,1,40 Participants
28-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D1, Score 0, n=3,8,4,102 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D22, Score 1, n=0,0,0,10 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IScreening, Score 0, n=3,9,4,103 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IScreening, Score 1, n=3,9,4,107 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IScreening, Score 2, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IScreening, Score 3, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC1D1, Score 0, n=3,9,4,103 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC1D1, Score 1, n=3,9,4,107 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC1D1, Score 2, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC1D1, Score 3, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D1, Score 0, n=3,8,4,102 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D1, Score 1, n=3,8,4,108 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D1, Score 2, n=3,8,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D1, Score 3, n=3,8,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D8, Score 0, n=1,0,1,0NA Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D8, Score 1, n=1,0,1,0NA Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D8, Score 2, n=1,0,1,0NA Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D8, Score 3, n=1,0,1,0NA Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D15, Score 0, n=0,1,0,10 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D15, Score 1, n=0,1,0,11 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D15, Score 2, n=0,1,0,10 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC2D15, Score 3, n=0,1,0,10 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC3D1, Score 0, n=2,6,2,74 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC3D1, Score 1, n=2,6,2,73 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC3D1, Score 2, n=2,6,2,70 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC3D1, Score 3, n=2,6,2,70 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D1, Score 0, n=2,6,1,74 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D1, Score 1, n=2,6,1,73 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D1, Score 2, n=2,6,1,70 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D1, Score 3, n=2,6,1,70 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D22, Score 0, n=0,0,0,10 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D22, Score 2, n=0,0,0,11 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC4D22, Score 3, n=0,0,0,10 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D1, Score 0, n=1,3,1,42 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D1, Score 1, n=1,3,1,42 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D1, Score 2, n=1,3,1,40 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D1, Score 3, n=1,3,1,40 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D8, Score 0, n=0,1,0,0NA Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D8, Score 1, n=0,1,0,0NA Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D8, Score 2, n=0,1,0,0NA Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC5D8, Score 3, n=0,1,0,0NA Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D1, Score 0, n=1,1,1,42 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D1, Score 1, n=1,1,1,42 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D1, Score 2, n=1,1,1,40 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D1, Score 3, n=1,1,1,40 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D15, Score 0, n=0,0,0,10 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D15, Score 1, n=0,0,0,11 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D15, Score 2, n=0,0,0,10 Participants
28-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IC6D15, Score 3, n=0,0,0,10 Participants
Secondary

Average Daily Area Under the Platelet-time Course Across Cycles 1 to 6 in Phase II

The average daily area under the platelet-time course was normalized by dividing the area under curve by total duration. This gives an estimated average platelet value over the time period from cycles 1 to 6. Blood samples were collected to estimate platelet count at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6.

Time frame: All assessments from Cycle 1 Day 1 to last assessment in Cycle 6

Population: ITT Population:Participants with platelet count data in at least one cycle in the study.

ArmMeasureValue (MEAN)Dispersion
21-Day Cycle PlaceboAverage Daily Area Under the Platelet-time Course Across Cycles 1 to 6 in Phase II153.00 Giga (10^9) cells per liter (G cells/L)Standard Deviation 96.079
21-Day Cycle Eltrombopag 100 mgAverage Daily Area Under the Platelet-time Course Across Cycles 1 to 6 in Phase II189.48 Giga (10^9) cells per liter (G cells/L)Standard Deviation 79.583
Secondary

Average Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase I

Pre-chemotherapy platelet count is defined for Cycle 1 as the platelet count (from central laboratory data) immediately preceding the first dose of chemotherapy within Cycle 1. For all subsequent cycles it is defined as the platelet count (from central laboratory data) immediately preceding, but limited to within 2 days prior to the first dose of chemotherapy at Day 1. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet count at the following time points: Group A; Days 1 and 8 of Cycles 1 to 6. Group B; Days 1, 8 and 15 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).

Time frame: C1D1, C1D8, C1D15, C2D1, C2D8, C2D15, C3D1, C3D8, C3D15, C4D1,C4D8, C4D15, C5D1,C5D8, C5D15, C6D1,C6D8 and C6D15

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
21-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC4 D1, n=1,6,1,6298.0 Giga (10^9) cells per liter (G cells/L)
21-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC3 D15, n=0,0,2,5NA Giga (10^9) cells per liter (G cells/L)
21-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC2 D15, n=0,0,2,6NA Giga (10^9) cells per liter (G cells/L)
21-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC6 D15, n=0,0,1,2NA Giga (10^9) cells per liter (G cells/L)
21-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC3 D8, n=2,6,2,5285.0 Giga (10^9) cells per liter (G cells/L)Standard Deviation 39.6
21-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC3 D1, n=2,5,2,7464.0 Giga (10^9) cells per liter (G cells/L)Standard Deviation 36.77
21-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC6 D1, n=1,1,1,3512.0 Giga (10^9) cells per liter (G cells/L)
21-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC5 D15, n=0,0,1,4NA Giga (10^9) cells per liter (G cells/L)
21-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC1 D15, n=0,0,2, 6NA Giga (10^9) cells per liter (G cells/L)
21-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC1 D1, n=3,9,4,9239.3 Giga (10^9) cells per liter (G cells/L)Standard Deviation 75.87
21-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC5 D8, n=1,1,1,4144.0 Giga (10^9) cells per liter (G cells/L)
21-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC5 D1, n=1,2,1,4245.0 Giga (10^9) cells per liter (G cells/L)
21-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC2 D1, n=2,9,4,8443.0 Giga (10^9) cells per liter (G cells/L)Standard Deviation 168.29
21-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC6 D8, n=1,1,0,3251.0 Giga (10^9) cells per liter (G cells/L)
21-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC4 D15, n=0,0,1,6NA Giga (10^9) cells per liter (G cells/L)
21-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC4 D8, n=1,5,1,6261.0 Giga (10^9) cells per liter (G cells/L)
21-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC2 D8, n=2,7,3,9221.0 Giga (10^9) cells per liter (G cells/L)Standard Deviation 94.75
21-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC1 D8, n=3,6,3,9180.7 Giga (10^9) cells per liter (G cells/L)Standard Deviation 65.03
21-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC1 D15, n=0,0,2, 6NA Giga (10^9) cells per liter (G cells/L)
21-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC1 D1, n=3,9,4,9244.8 Giga (10^9) cells per liter (G cells/L)Standard Deviation 48.47
21-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC1 D8, n=3,6,3,9143.8 Giga (10^9) cells per liter (G cells/L)Standard Deviation 33.88
21-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC2 D1, n=2,9,4,8545.8 Giga (10^9) cells per liter (G cells/L)Standard Deviation 131.66
21-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC2 D8, n=2,7,3,9335.6 Giga (10^9) cells per liter (G cells/L)Standard Deviation 134.06
21-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC2 D15, n=0,0,2,6NA Giga (10^9) cells per liter (G cells/L)
21-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC3 D1, n=2,5,2,7484.6 Giga (10^9) cells per liter (G cells/L)Standard Deviation 188.16
21-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC3 D8, n=2,6,2,5292.2 Giga (10^9) cells per liter (G cells/L)Standard Deviation 161.11
21-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC3 D15, n=0,0,2,5NA Giga (10^9) cells per liter (G cells/L)
21-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC4 D1, n=1,6,1,6394.7 Giga (10^9) cells per liter (G cells/L)Standard Deviation 154.28
21-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC4 D8, n=1,5,1,6249.8 Giga (10^9) cells per liter (G cells/L)Standard Deviation 122.29
21-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC4 D15, n=0,0,1,6NA Giga (10^9) cells per liter (G cells/L)
21-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC5 D1, n=1,2,1,4529.5 Giga (10^9) cells per liter (G cells/L)Standard Deviation 340.12
21-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC5 D8, n=1,1,1,4123.0 Giga (10^9) cells per liter (G cells/L)
21-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC5 D15, n=0,0,1,4NA Giga (10^9) cells per liter (G cells/L)
21-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC6 D1, n=1,1,1,3123.0 Giga (10^9) cells per liter (G cells/L)
21-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC6 D8, n=1,1,0,3137.0 Giga (10^9) cells per liter (G cells/L)
21-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC6 D15, n=0,0,1,2NA Giga (10^9) cells per liter (G cells/L)
28-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC2 D8, n=2,7,3,9163.3 Giga (10^9) cells per liter (G cells/L)Standard Deviation 35.3
28-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC4 D1, n=1,6,1,6609.0 Giga (10^9) cells per liter (G cells/L)
28-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC4 D8, n=1,5,1,6335.0 Giga (10^9) cells per liter (G cells/L)
28-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC2 D1, n=2,9,4,8284.8 Giga (10^9) cells per liter (G cells/L)Standard Deviation 84.11
28-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC6 D15, n=0,0,1,2113.0 Giga (10^9) cells per liter (G cells/L)
28-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC4 D15, n=0,0,1,686.0 Giga (10^9) cells per liter (G cells/L)
28-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC6 D8, n=1,1,0,3NA Giga (10^9) cells per liter (G cells/L)
28-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC5 D1, n=1,2,1,4337.0 Giga (10^9) cells per liter (G cells/L)
28-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC1 D15, n=0,0,2, 6135.0 Giga (10^9) cells per liter (G cells/L)Standard Deviation 84.85
28-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC5 D8, n=1,1,1,4311.0 Giga (10^9) cells per liter (G cells/L)
28-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC1 D1, n=3,9,4,9223.8 Giga (10^9) cells per liter (G cells/L)Standard Deviation 79.96
28-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC5 D15, n=0,0,1,475.0 Giga (10^9) cells per liter (G cells/L)
28-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC1 D8, n=3,6,3,9144.0 Giga (10^9) cells per liter (G cells/L)Standard Deviation 44.17
28-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC3 D1, n=2,5,2,7290.5 Giga (10^9) cells per liter (G cells/L)Standard Deviation 180.31
28-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC2 D15, n=0,0,2,680.5 Giga (10^9) cells per liter (G cells/L)Standard Deviation 0.71
28-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC3 D8, n=2,6,2,5293.0 Giga (10^9) cells per liter (G cells/L)Standard Deviation 199.4
28-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC6 D1, n=1,1,1,3440.0 Giga (10^9) cells per liter (G cells/L)
28-Day Cycle PlaceboAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC3 D15, n=0,0,2,592.0 Giga (10^9) cells per liter (G cells/L)Standard Deviation 45.25
28-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC3 D1, n=2,5,2,7435.4 Giga (10^9) cells per liter (G cells/L)Standard Deviation 145.57
28-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC6 D1, n=1,1,1,3360.3 Giga (10^9) cells per liter (G cells/L)Standard Deviation 133.45
28-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC5 D8, n=1,1,1,4403.5 Giga (10^9) cells per liter (G cells/L)Standard Deviation 195.31
28-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC4 D1, n=1,6,1,6388.3 Giga (10^9) cells per liter (G cells/L)Standard Deviation 166.07
28-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC2 D1, n=2,9,4,8473.3 Giga (10^9) cells per liter (G cells/L)Standard Deviation 117.07
28-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC1 D1, n=3,9,4,9207.7 Giga (10^9) cells per liter (G cells/L)Standard Deviation 65.51
28-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC1 D8, n=3,6,3,9135.6 Giga (10^9) cells per liter (G cells/L)Standard Deviation 52.52
28-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC4 D8, n=1,5,1,6366.5 Giga (10^9) cells per liter (G cells/L)Standard Deviation 143.75
28-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC2 D8, n=2,7,3,9333.0 Giga (10^9) cells per liter (G cells/L)Standard Deviation 146.59
28-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC6 D15, n=0,0,1,2101.0 Giga (10^9) cells per liter (G cells/L)Standard Deviation 48.08
28-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC5 D15, n=0,0,1,4140.5 Giga (10^9) cells per liter (G cells/L)Standard Deviation 42.93
28-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC4 D15, n=0,0,1,6169.8 Giga (10^9) cells per liter (G cells/L)Standard Deviation 120.56
28-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC1 D15, n=0,0,2, 697.5 Giga (10^9) cells per liter (G cells/L)Standard Deviation 39.15
28-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC2 D15, n=0,0,2,6142.7 Giga (10^9) cells per liter (G cells/L)Standard Deviation 63.14
28-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC3 D15, n=0,0,2,5183.4 Giga (10^9) cells per liter (G cells/L)Standard Deviation 119.12
28-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC5 D1, n=1,2,1,4406.0 Giga (10^9) cells per liter (G cells/L)Standard Deviation 174.89
28-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC3 D8, n=2,6,2,5465.2 Giga (10^9) cells per liter (G cells/L)Standard Deviation 260.2
28-Day Cycle Eltrombopag 100 mgAverage Pre-chemotherapy Platelet Count at the Indicated Time Points in Phase IC6 D8, n=1,1,0,3428.0 Giga (10^9) cells per liter (G cells/L)Standard Deviation 210.71
Secondary

Average Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase I

Within-subject platelet count for each participant was calculated by summing up the visit platelet counts from each of Cycles 1 to 6 and dividing it by the number of cycles in which the participant had data. The average within a treatment group was calculated by summing up the values from each participant within the treatment group and dividing it by the number of participants. These platelet counts are different from the pre-chemotherapy platelet counts for cycles where the chemotherapy dose was delayed. Average within-subject central laboratory platelet count prior to scheduled chemotherapy across Cycles 2 to 6 are summarized. Blood samples were collected on Days 1 and 8 of Cycles 2 to 6 for Group A and on Days 1, 8 and 15 from Cycles 2 to 6 for Group B to estimate the average within subject platelet count prior to scheduled chemotherapy. Only those participants available at the indicated time points were analyzed (represented by n=X,X,X,X in the category titles).

Time frame: Day 1 (averaged across Cycles 2 to 6), Day 8 (averaged across Cycles 2 to 6)

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
21-Day Cycle PlaceboAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IGm, Day15, n=0,0,3,10NA Giga (10^9) cells per liter (G cells/L)
21-Day Cycle PlaceboAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IG+Cb, Day 1, n=1,3,0,0296.80 Giga (10^9) cells per liter (G cells/L)
21-Day Cycle PlaceboAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IG+Cis, Day 8, n=2,6,0,0326.85 Giga (10^9) cells per liter (G cells/L)Standard Deviation 119.006
21-Day Cycle PlaceboAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IG+Cis, Day 1, n=2,6,0,0322.50 Giga (10^9) cells per liter (G cells/L)Standard Deviation 82.731
21-Day Cycle PlaceboAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IG+Cb, Day 8, n=1,3,0,0235.00 Giga (10^9) cells per liter (G cells/L)
21-Day Cycle PlaceboAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IGm, Day8, n=0,0,4,10NA Giga (10^9) cells per liter (G cells/L)
21-Day Cycle PlaceboAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IGm, Day1, n=0,0,4,9NA Giga (10^9) cells per liter (G cells/L)
21-Day Cycle Eltrombopag 100 mgAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IG+Cb, Day 8, n=1,3,0,0232.10 Giga (10^9) cells per liter (G cells/L)Standard Deviation 77.329
21-Day Cycle Eltrombopag 100 mgAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IG+Cb, Day 1, n=1,3,0,0275.00 Giga (10^9) cells per liter (G cells/L)Standard Deviation 144.253
21-Day Cycle Eltrombopag 100 mgAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IGm, Day8, n=0,0,4,10NA Giga (10^9) cells per liter (G cells/L)
21-Day Cycle Eltrombopag 100 mgAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IG+Cis, Day 1, n=2,6,0,0526.00 Giga (10^9) cells per liter (G cells/L)Standard Deviation 86.408
21-Day Cycle Eltrombopag 100 mgAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IGm, Day1, n=0,0,4,9NA Giga (10^9) cells per liter (G cells/L)
21-Day Cycle Eltrombopag 100 mgAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IG+Cis, Day 8, n=2,6,0,0296.75 Giga (10^9) cells per liter (G cells/L)Standard Deviation 119.342
21-Day Cycle Eltrombopag 100 mgAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IGm, Day15, n=0,0,3,10NA Giga (10^9) cells per liter (G cells/L)
28-Day Cycle PlaceboAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IG+Cb, Day 1, n=1,3,0,0NA Giga (10^9) cells per liter (G cells/L)
28-Day Cycle PlaceboAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IG+Cb, Day 8, n=1,3,0,0NA Giga (10^9) cells per liter (G cells/L)
28-Day Cycle PlaceboAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IG+Cis, Day 1, n=2,6,0,0NA Giga (10^9) cells per liter (G cells/L)
28-Day Cycle PlaceboAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IG+Cis, Day 8, n=2,6,0,0NA Giga (10^9) cells per liter (G cells/L)
28-Day Cycle PlaceboAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IGm, Day1, n=0,0,4,9309.20 Giga (10^9) cells per liter (G cells/L)Standard Deviation 123.133
28-Day Cycle PlaceboAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IGm, Day8, n=0,0,4,10204.20 Giga (10^9) cells per liter (G cells/L)Standard Deviation 80.822
28-Day Cycle PlaceboAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IGm, Day15, n=0,0,3,1075.37 Giga (10^9) cells per liter (G cells/L)Standard Deviation 18.292
28-Day Cycle Eltrombopag 100 mgAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IGm, Day1, n=0,0,4,9442.79 Giga (10^9) cells per liter (G cells/L)Standard Deviation 114.593
28-Day Cycle Eltrombopag 100 mgAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IG+Cis, Day 8, n=2,6,0,0NA Giga (10^9) cells per liter (G cells/L)
28-Day Cycle Eltrombopag 100 mgAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IG+Cb, Day 1, n=1,3,0,0NA Giga (10^9) cells per liter (G cells/L)
28-Day Cycle Eltrombopag 100 mgAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IGm, Day15, n=0,0,3,10164.24 Giga (10^9) cells per liter (G cells/L)Standard Deviation 94.905
28-Day Cycle Eltrombopag 100 mgAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IG+Cis, Day 1, n=2,6,0,0NA Giga (10^9) cells per liter (G cells/L)
28-Day Cycle Eltrombopag 100 mgAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IG+Cb, Day 8, n=1,3,0,0NA Giga (10^9) cells per liter (G cells/L)
28-Day Cycle Eltrombopag 100 mgAverage Within-subject Central Laboratory Platelet Count Prior to Scheduled Chemotherapy Across Cycles 2 to 6 in Phase IGm, Day8, n=0,0,4,10355.09 Giga (10^9) cells per liter (G cells/L)Standard Deviation 148.539
Secondary

Central Laboratory Average Daily Area Under the Curve Platelet-time Course Across Cycles 2 to 6 in Phase I

The average daily area under the platelet-time course was normalized by dividing the area under curve by total duration. This gives an estimated average platelet value over the time period from cycles 2 to 6. For 21-Day Cycle, the chemotherapy cycle consisted of 21 days and for 28-Day Cycle, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate thrombocytes at the following time points: 21-Day Cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-Day Cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6.

Time frame: All assessments from Cycle 2 Day 1 to last assessment in Cycle 6

Population: Safety Population

ArmMeasureValue (MEAN)Dispersion
21-Day Cycle PlaceboCentral Laboratory Average Daily Area Under the Curve Platelet-time Course Across Cycles 2 to 6 in Phase I260.97 Giga (10^9) cells per liter (G cells/L)Standard Deviation 67.581
21-Day Cycle Eltrombopag 100 mgCentral Laboratory Average Daily Area Under the Curve Platelet-time Course Across Cycles 2 to 6 in Phase I307.59 Giga (10^9) cells per liter (G cells/L)Standard Deviation 95.11
28-Day Cycle PlaceboCentral Laboratory Average Daily Area Under the Curve Platelet-time Course Across Cycles 2 to 6 in Phase I183.68 Giga (10^9) cells per liter (G cells/L)Standard Deviation 55.366
28-Day Cycle Eltrombopag 100 mgCentral Laboratory Average Daily Area Under the Curve Platelet-time Course Across Cycles 2 to 6 in Phase I291.18 Giga (10^9) cells per liter (G cells/L)Standard Deviation 99.718
Secondary

Central Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase I

Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. The time taken to reach platelet nadir is defined within each cycle. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet nadir count at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).

Time frame: Cycle 1 to Cycle 6

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
21-Day Cycle PlaceboCentral Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase ICycle 1, n=3,9,4,1015.7 DaysStandard Deviation 0.58
21-Day Cycle PlaceboCentral Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase ICycle 2, n=2,9,4,1015.0 DaysStandard Deviation 1.41
21-Day Cycle PlaceboCentral Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase ICycle 3, n=2,7,2,715.0 DaysStandard Deviation 1.41
21-Day Cycle PlaceboCentral Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase ICycle 4, n=2,6,1,714.0 DaysStandard Deviation 0
21-Day Cycle PlaceboCentral Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase ICycle 5, n=1,2,1,415.0 Days
21-Day Cycle PlaceboCentral Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase ICycle 6, n=1,1,1,416.0 Days
21-Day Cycle Eltrombopag 100 mgCentral Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase ICycle 6, n=1,1,1,414.0 Days
21-Day Cycle Eltrombopag 100 mgCentral Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase ICycle 4, n=2,6,1,713.5 DaysStandard Deviation 3.33
21-Day Cycle Eltrombopag 100 mgCentral Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase ICycle 1, n=3,9,4,1011.4 DaysStandard Deviation 5.53
21-Day Cycle Eltrombopag 100 mgCentral Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase ICycle 3, n=2,7,2,712.9 DaysStandard Deviation 3.02
21-Day Cycle Eltrombopag 100 mgCentral Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase ICycle 2, n=2,9,4,1012.9 DaysStandard Deviation 4.68
21-Day Cycle Eltrombopag 100 mgCentral Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase ICycle 5, n=1,2,1,411.5 DaysStandard Deviation 6.36
28-Day Cycle PlaceboCentral Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase ICycle 2, n=2,9,4,1014.0 DaysStandard Deviation 5.72
28-Day Cycle PlaceboCentral Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase ICycle 3, n=2,7,2,723.5 DaysStandard Deviation 0.71
28-Day Cycle PlaceboCentral Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase ICycle 4, n=2,6,1,714.0 Days
28-Day Cycle PlaceboCentral Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase ICycle 6, n=1,1,1,423.0 Days
28-Day Cycle PlaceboCentral Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase ICycle 5, n=1,2,1,414.0 Days
28-Day Cycle PlaceboCentral Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase ICycle 1, n=3,9,4,1013.8 DaysStandard Deviation 6.13
28-Day Cycle Eltrombopag 100 mgCentral Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase ICycle 5, n=1,2,1,421.5 DaysStandard Deviation 1
28-Day Cycle Eltrombopag 100 mgCentral Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase ICycle 6, n=1,1,1,415.5 DaysStandard Deviation 5.2
28-Day Cycle Eltrombopag 100 mgCentral Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase ICycle 2, n=2,9,4,1019.2 DaysStandard Deviation 4.42
28-Day Cycle Eltrombopag 100 mgCentral Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase ICycle 4, n=2,6,1,717.4 DaysStandard Deviation 6.16
28-Day Cycle Eltrombopag 100 mgCentral Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase ICycle 1, n=3,9,4,1013.8 DaysStandard Deviation 4.73
28-Day Cycle Eltrombopag 100 mgCentral Laboratory Platelet Count for Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase ICycle 3, n=2,7,2,717.6 DaysStandard Deviation 4.5
Secondary

Dose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase II

Dose intensity of chemotherapy is defined as the actual dose of chemotherapy given as a percentage of the scheduled C1D1/C1D8 dose, as applicable, within this study: cycle Dose Intensity (%) = Total Actual dose (mg/m\^2) within cycle \*100/ Total Scheduled dose (mg/m\^2) in Cycle 1; wherein Actual Dose (mg/m\^2) = Actual dose (mg)/Body Surface Area reported on eCRF. The average chemotherapy dose intensity at Day 1 across Cycles 1 to 6, Day 8 across Cycles 1 to 6 and Day 15 across Cycles 1 to 6 was summarized and compared between treatment groups using an ANCOVA model adjusted for cycle duration and part of the study.

Time frame: Cycle 1 to Cycle 6

Population: ITT Population

ArmMeasureGroupValue (MEAN)Dispersion
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase IICycle 6, n=5,784.4 Dose Intensity (%)Standard Deviation 21.92
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase IICycle 1, n=23,4896.6 Dose Intensity (%)Standard Deviation 10.65
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase IICycle 2, n=19,37113.1 Dose Intensity (%)Standard Deviation 33.91
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase IICycle 3, n=13,26102.6 Dose Intensity (%)Standard Deviation 42.2
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase IICycle 4, n=11,1996.6 Dose Intensity (%)Standard Deviation 27.65
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase IICycle 5, n=6,12102.2 Dose Intensity (%)Standard Deviation 31.88
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase IICycle 1-6, n=23,4998.5 Dose Intensity (%)Standard Deviation 18.26
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase IICycle 6, n=5,765.2 Dose Intensity (%)Standard Deviation 25.48
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase IICycle 4, n=11,1990.7 Dose Intensity (%)Standard Deviation 30
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase IICycle 1, n=23,4897.9 Dose Intensity (%)Standard Deviation 6.19
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase IICycle 1-6, n=23,4994.6 Dose Intensity (%)Standard Deviation 15.71
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase IICycle 2, n=19,3797.8 Dose Intensity (%)Standard Deviation 24.99
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase IICycle 5, n=6,1281.3 Dose Intensity (%)Standard Deviation 25.39
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin(G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1-6 in Phase IICycle 3, n=13,2698.7 Dose Intensity (%)Standard Deviation 35.77
Secondary

Dose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase I

Dose intensity of chemotherapy is defined as the actual dose of chemotherapy given as a percentage of the scheduled C1D1/C1D8 dose, as applicable, within this study: Cycle Dose Intensity (%) = Total Actual dose (mg/m\^2) within Cycle \*100/ Total Scheduled dose (mg/m\^2) in Cycle 1; wherein Actual Dose (mg/m\^2) = Actual dose (mg)/Body Surface Area reported on electronic case report form (eCRF).

Time frame: Cycle 1 to Cycle 6

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Carboplatin, Cycle 5, n=1,1,0,0100.0 Dose Intensity (%)
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Cisplatin, Cycle 4, n=1,4,0,0100.0 Dose Intensity (%)
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Carboplatin, Cycle 3, n=1,2,0,093.0 Dose Intensity (%)
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Gemcitabine, Cycle 3, n=1,4,0,0100.0 Dose Intensity (%)
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Gemcitabine, Cycle 6, n=1,1,0,099.0 Dose Intensity (%)
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Cisplatin, Cycle 5, n=0,1,0,0NA Dose Intensity (%)
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Gemcitabine, Cycle 2, n=1,5,0,0100.0 Dose Intensity (%)
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Cisplatin, Cycle 1, n=2,6,0,0100.0 Dose Intensity (%)Standard Deviation 0
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IGemcitabine, Cycle 3, n=0,0,1,4NA Dose Intensity (%)
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Gemcitabine, Cycle 1, n=1,2,0,099.0 Dose Intensity (%)
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Carboplatin, Cycle 4, n=1,2,0,091.0 Dose Intensity (%)
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Gemcitabine, Cycle 1, n=2,5,0,0100.0 Dose Intensity (%)Standard Deviation 0
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IGemcitabine, Cycle 5, n=0,0,0,3NA Dose Intensity (%)
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Gemcitabine, Cycle 2, n=1,2,0,099.0 Dose Intensity (%)
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Cisplatin, Cycle 2, n=1,6,0,0100.0 Dose Intensity (%)
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Carboplatin, Cycle 2, n=1,3,0,0100.0 Dose Intensity (%)
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IGemcitabine, Cycle 2, n=0,0,1,7NA Dose Intensity (%)
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Gemcitabine, Cycle 3, n=1,2,0,099.0 Dose Intensity (%)
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Carboplatin, Cycle 6, n=1,1,0,087.0 Dose Intensity (%)
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Gemcitabine, Cycle 4, n=1,3,0,0100.0 Dose Intensity (%)
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IGemcitabine, Cycle 4, n=0,0,0,4NA Dose Intensity (%)
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Gemcitabine, Cycle 4, n=1,2,0,049.0 Dose Intensity (%)
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Cisplatin, Cycle 3, n=1,5,0,0100.0 Dose Intensity (%)
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Carboplatin, Cycle 1, n=1,3,0,0101.0 Dose Intensity (%)
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IGemcitabine, Cycle 1, n=0,0,1,7NA Dose Intensity (%)
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Gemcitabine, Cycle 5, n=1,1,0,099.0 Dose Intensity (%)
21-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IGemcitabine, Cycle 6, n=0,0,0,3NA Dose Intensity (%)
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Gemcitabine, Cycle 5, n=1,1,0,074.0 Dose Intensity (%)
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Carboplatin, Cycle 6, n=1,1,0,079.0 Dose Intensity (%)
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Gemcitabine, Cycle 6, n=1,1,0,074.0 Dose Intensity (%)
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Carboplatin, Cycle 1, n=1,3,0,088.7 Dose Intensity (%)Standard Deviation 14.05
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Carboplatin, Cycle 5, n=1,1,0,071.0 Dose Intensity (%)
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Carboplatin, Cycle 2, n=1,3,0,0103.0 Dose Intensity (%)Standard Deviation 5.2
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Cisplatin, Cycle 1, n=2,6,0,0100.3 Dose Intensity (%)Standard Deviation 1.03
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Carboplatin, Cycle 3, n=1,2,0,0105.0 Dose Intensity (%)Standard Deviation 5.66
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Carboplatin, Cycle 4, n=1,2,0,0107.5 Dose Intensity (%)Standard Deviation 2.12
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IGemcitabine, Cycle 4, n=0,0,0,4NA Dose Intensity (%)
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Cisplatin, Cycle 2, n=1,6,0,0102.8 Dose Intensity (%)Standard Deviation 6.05
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Gemcitabine, Cycle 1, n=2,5,0,099.8 Dose Intensity (%)Standard Deviation 0.45
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Cisplatin, Cycle 3, n=1,5,0,093.8 Dose Intensity (%)Standard Deviation 24.34
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Gemcitabine, Cycle 2, n=1,5,0,092.8 Dose Intensity (%)Standard Deviation 24.83
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Cisplatin, Cycle 4, n=1,4,0,0100.3 Dose Intensity (%)Standard Deviation 0.96
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IGemcitabine, Cycle 3, n=0,0,1,4NA Dose Intensity (%)
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Cisplatin, Cycle 5, n=0,1,0,050 Dose Intensity (%)
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Gemcitabine, Cycle 3, n=1,4,0,0104.3 Dose Intensity (%)Standard Deviation 8.5
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Gemcitabine, Cycle 1, n=1,2,0,0100.0 Dose Intensity (%)Standard Deviation 0
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IGemcitabine, Cycle 2, n=0,0,1,7NA Dose Intensity (%)
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Gemcitabine, Cycle 2, n=1,2,0,088.5 Dose Intensity (%)Standard Deviation 17.68
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IGemcitabine, Cycle 5, n=0,0,0,3NA Dose Intensity (%)
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Gemcitabine, Cycle 3, n=1,2,0,0100.0 Dose Intensity (%)Standard Deviation 0
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IGemcitabine, Cycle 1, n=0,0,1,7NA Dose Intensity (%)
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Gemcitabine, Cycle 4, n=1,2,0,099.5 Dose Intensity (%)Standard Deviation 0.71
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Gemcitabine, Cycle 4, n=1,3,0,083.3 Dose Intensity (%)Standard Deviation 28.87
21-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IGemcitabine, Cycle 6, n=0,0,0,3NA Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IGemcitabine, Cycle 3, n=0,0,1,4100.0 Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Gemcitabine, Cycle 1, n=2,5,0,0NA Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Gemcitabine, Cycle 2, n=1,5,0,0NA Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Gemcitabine, Cycle 3, n=1,4,0,0NA Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Gemcitabine, Cycle 4, n=1,3,0,0NA Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Cisplatin, Cycle 1, n=2,6,0,0NA Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Cisplatin, Cycle 2, n=1,6,0,0NA Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Cisplatin, Cycle 3, n=1,5,0,0NA Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Cisplatin, Cycle 4, n=1,4,0,0NA Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Cisplatin, Cycle 5, n=0,1,0,0NA Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Gemcitabine, Cycle 1, n=1,2,0,0NA Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Gemcitabine, Cycle 2, n=1,2,0,0NA Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Gemcitabine, Cycle 3, n=1,2,0,0NA Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Gemcitabine, Cycle 4, n=1,2,0,0NA Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Gemcitabine, Cycle 5, n=1,1,0,0NA Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Gemcitabine, Cycle 6, n=1,1,0,0NA Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Carboplatin, Cycle 1, n=1,3,0,0NA Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Carboplatin, Cycle 2, n=1,3,0,0NA Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Carboplatin, Cycle 3, n=1,2,0,0NA Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Carboplatin, Cycle 4, n=1,2,0,0NA Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Carboplatin, Cycle 5, n=1,1,0,0NA Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Carboplatin, Cycle 6, n=1,1,0,0NA Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IGemcitabine, Cycle 1, n=0,0,1,7100.0 Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IGemcitabine, Cycle 2, n=0,0,1,7100.0 Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IGemcitabine, Cycle 4, n=0,0,0,4NA Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IGemcitabine, Cycle 5, n=0,0,0,3NA Dose Intensity (%)
28-Day Cycle PlaceboDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IGemcitabine, Cycle 6, n=0,0,0,3NA Dose Intensity (%)
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Gemcitabine, Cycle 5, n=1,1,0,0NA Dose Intensity (%)
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IGemcitabine, Cycle 6, n=0,0,0,372.7 Dose Intensity (%)Standard Deviation 17.01
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Carboplatin, Cycle 6, n=1,1,0,0NA Dose Intensity (%)
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Gemcitabine, Cycle 4, n=1,2,0,0NA Dose Intensity (%)
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Gemcitabine, Cycle 3, n=1,2,0,0NA Dose Intensity (%)
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IGemcitabine, Cycle 5, n=0,0,0,393.7 Dose Intensity (%)Standard Deviation 3.79
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IGemcitabine, Cycle 1, n=0,0,1,794.7 Dose Intensity (%)Standard Deviation 6.75
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Gemcitabine, Cycle 2, n=1,2,0,0NA Dose Intensity (%)
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Gemcitabine, Cycle 1, n=1,2,0,0NA Dose Intensity (%)
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Gemcitabine, Cycle 2, n=1,5,0,0NA Dose Intensity (%)
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IGemcitabine, Cycle 2, n=0,0,1,785.0 Dose Intensity (%)Standard Deviation 17.48
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Cisplatin, Cycle 5, n=0,1,0,0NA Dose Intensity (%)
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Cisplatin, Cycle 4, n=1,4,0,0NA Dose Intensity (%)
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Cisplatin, Cycle 3, n=1,5,0,0NA Dose Intensity (%)
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IGemcitabine, Cycle 3, n=0,0,1,479.5 Dose Intensity (%)Standard Deviation 21.44
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Cisplatin, Cycle 2, n=1,6,0,0NA Dose Intensity (%)
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Cisplatin, Cycle 1, n=2,6,0,0NA Dose Intensity (%)
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Gemcitabine, Cycle 1, n=2,5,0,0NA Dose Intensity (%)
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IGemcitabine, Cycle 4, n=0,0,0,494.8 Dose Intensity (%)Standard Deviation 4.11
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Carboplatin, Cycle 3, n=1,2,0,0NA Dose Intensity (%)
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Gemcitabine, Cycle 4, n=1,3,0,0NA Dose Intensity (%)
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Carboplatin, Cycle 4, n=1,2,0,0NA Dose Intensity (%)
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Carboplatin, Cycle 2, n=1,3,0,0NA Dose Intensity (%)
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Carboplatin, Cycle 1, n=1,3,0,0NA Dose Intensity (%)
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cis, Gemcitabine, Cycle 3, n=1,4,0,0NA Dose Intensity (%)
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Carboplatin, Cycle 5, n=1,1,0,0NA Dose Intensity (%)
28-Day Cycle Eltrombopag 100 mgDose Intensity of Gemcitabine Plus Cisplatin (G+Cis)/Gemcitabine Plus Carboplatin (G+Cb) and Gemcitabine Across Chemotherapy Cycles 1 to 6 in Phase IG+Cb, Gemcitabine, Cycle 6, n=1,1,0,0NA Dose Intensity (%)
Secondary

Maximum Duration of Thrombocytopenia Across Cycles 1 to 6 in Phase II

Duration of thrombocytopenia is defined as a period of time in days from the first report of a platelet count with NCI CTCAE Grade 1-4 until the first subsequent report of a platelet count no longer meeting those criteria, regardless of rescue medication usage. It was assessed between Day 1 of Cycle 2 and up to and including any Conclusion/Early Withdrawal visit assigned to the same cycle for participants completing up to 6 cycles, and between Day 1 of Cycle 2 and up to and including the end of Cycle 6 for participants continuing beyond 6 cycles. The chemotherapy cycle for 21-day cycle was 21 days and for 28-day cycle was 28 days. Blood samples were collected to estimate thrombocytes at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 2 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 2 to 6.

Time frame: Cycle 1 to Cycle 6

Population: ITT Population: Participants with at least one period of thrombocytopenia where duration could be calculated.

ArmMeasureValue (MEAN)Dispersion
21-Day Cycle PlaceboMaximum Duration of Thrombocytopenia Across Cycles 1 to 6 in Phase II32.6 DaysStandard Deviation 20.31
21-Day Cycle Eltrombopag 100 mgMaximum Duration of Thrombocytopenia Across Cycles 1 to 6 in Phase II23.5 DaysStandard Deviation 18.68
Secondary

Maximum Duration of Thrombocytopenia Across Cycles 2 to 6 in Phase I, Estimated Using Central Laboratory Platelet Counts

Duration of thrombocytopenia is defined as a period of time in days from the first report of a platelet count with NCI CTCAE Grade 1-4 until the first subsequent report of a platelet count no longer meeting those criteria, regardless of rescue medication usage. It was assessed between Day 1 of Cycle 2 and up to and including any Conclusion/Early Withdrawal visit assigned to the same cycle for participants completing up to 6 cycles, and between Day 1 of Cycle 2 and up to and including the end of Cycle 6 for participants continuing beyond 6 cycles. The chemotherapy cycle for Group A was 21 days and for Group B was 28 days. Blood samples were collected to estimate thrombocytes at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 2 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 2 to 6.

Time frame: Cycle 2 to Cycle 6

Population: Safety Population. Participants experiencing thrombocytopenia with subsequent increase in platelet count to \>=150Gi/L are included.

ArmMeasureValue (MEAN)Dispersion
21-Day Cycle PlaceboMaximum Duration of Thrombocytopenia Across Cycles 2 to 6 in Phase I, Estimated Using Central Laboratory Platelet Counts11.0 DaysStandard Deviation 4.24
21-Day Cycle Eltrombopag 100 mgMaximum Duration of Thrombocytopenia Across Cycles 2 to 6 in Phase I, Estimated Using Central Laboratory Platelet Counts10.6 DaysStandard Deviation 5.63
28-Day Cycle PlaceboMaximum Duration of Thrombocytopenia Across Cycles 2 to 6 in Phase I, Estimated Using Central Laboratory Platelet Counts14.7 DaysStandard Deviation 7.77
28-Day Cycle Eltrombopag 100 mgMaximum Duration of Thrombocytopenia Across Cycles 2 to 6 in Phase I, Estimated Using Central Laboratory Platelet Counts13.4 DaysStandard Deviation 5.06
Secondary

Mean Day 15 Scheduled Pre-chemotherapy Platelet Counts Evaluated Across Cycles 1 to 6 in Phase II

Scheduled pre-chemotherapy platelet count is defined within each cycle as the platelet count assessment on which the decision to give or delay chemotherapy was made. This was averaged for each subject across cycles 1 to 6 and a natural log transformation was applied to the average. The log-transformed values were compared between eltrombopag and placebo groups using an analysis of covariance (ANCOVA) model adjusting for cycle duration (21-day vs. 28-day), baseline loge(platelet count) and part of study (part 1 or 2 of phase II). The number of participants analyzed is the number with a Day 15 scheduled platelet count.

Time frame: Day 15 (averaged across cycles 1 to 6)

Population: ITT Population

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
21-Day Cycle PlaceboMean Day 15 Scheduled Pre-chemotherapy Platelet Counts Evaluated Across Cycles 1 to 6 in Phase II95.10 Giga (10^9) cells per liter (G cells/L)Geometric Coefficient of Variation 23.3
21-Day Cycle Eltrombopag 100 mgMean Day 15 Scheduled Pre-chemotherapy Platelet Counts Evaluated Across Cycles 1 to 6 in Phase II95.29 Giga (10^9) cells per liter (G cells/L)Geometric Coefficient of Variation 52.1
p-value: 0.80295% CI: [-33.5, 37.4]ANCOVA
Secondary

Mean Day 8 Scheduled Pre-chemotherapy Platelet Counts Evaluated Across Cycles 1 to 6 in Phase II

Scheduled pre-chemotherapy platelet count is defined within each cycle as the platelet count assessment on which the decision to give or delay chemotherapy was made. This was averaged for each subject across cycles 1 to 6 and a natural log transformation was applied to the average. The log-transformed values were compared between eltrombopag and placebo groups using an analysis of covariance (ANCOVA) model adjusting for cycle duration (21-day vs. 28-day), baseline loge(platelet count) and part of study (part 1 or 2 of phase II). The number of participants analyzed is the number with a Day 8 scheduled platelet count.

Time frame: Day 8 (averaged across cycles 1 to 6)

Population: ITT Population

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
21-Day Cycle PlaceboMean Day 8 Scheduled Pre-chemotherapy Platelet Counts Evaluated Across Cycles 1 to 6 in Phase II162.18 Giga (10^9) cells per liter (G cells/L)Geometric Coefficient of Variation 74.2
21-Day Cycle Eltrombopag 100 mgMean Day 8 Scheduled Pre-chemotherapy Platelet Counts Evaluated Across Cycles 1 to 6 in Phase II180.65 Giga (10^9) cells per liter (G cells/L)Geometric Coefficient of Variation 59.1
p-value: 0.40795% CI: [-15.6, 51.1]ANCOVA
Secondary

Mean Within-subject Platelet Count Prior to Scheduled Chemotherapy Across Cycles 1 to 6 in Phase II

Within-subject platelet count for each par. was calculated by summing up the visit platelet counts from each of Cycles 1 to 6 and dividing it by the number of cycles in which the par. had data. The average within a treatment group was calculated by summing up the values from each par. within the treatment 21-day cycle dividing it by the number of par. These platelet counts are different from the pre-chemotherapy platelet counts for cycles where the chemotherapy dose was delayed. Average within-subject central laboratory platelet count prior to scheduled chemotherapy across Cycles 1 to 6 are summarized. Blood samples were collected on Day 1 and 8 of Cycles 1 to 6 for 21-day cycle and on Day 1, 8 and 15 from Cycles 1 to 6 for 28-day cycle to estimate the average within subject platelet count prior to scheduled chemotherapy. Only those participants available at the indicated time points were analyzed (represented by n=X,X in the category titles).

Time frame: Day 1, Day 8, Day 15 (all averaged across cycles 1 to 6)

Population: ITT Population

ArmMeasureGroupValue (MEAN)Dispersion
21-Day Cycle PlaceboMean Within-subject Platelet Count Prior to Scheduled Chemotherapy Across Cycles 1 to 6 in Phase IIDay1, n=23,48221.0 Giga (10^9) cells per liter (G cells/L)Standard Deviation 128.23
21-Day Cycle PlaceboMean Within-subject Platelet Count Prior to Scheduled Chemotherapy Across Cycles 1 to 6 in Phase IIDay 8, n=20,42201.0 Giga (10^9) cells per liter (G cells/L)Standard Deviation 143.75
21-Day Cycle PlaceboMean Within-subject Platelet Count Prior to Scheduled Chemotherapy Across Cycles 1 to 6 in Phase IIDay 15, n=9,2297.5 Giga (10^9) cells per liter (G cells/L)Standard Deviation 24.82
21-Day Cycle Eltrombopag 100 mgMean Within-subject Platelet Count Prior to Scheduled Chemotherapy Across Cycles 1 to 6 in Phase IIDay1, n=23,48272.9 Giga (10^9) cells per liter (G cells/L)Standard Deviation 120.92
21-Day Cycle Eltrombopag 100 mgMean Within-subject Platelet Count Prior to Scheduled Chemotherapy Across Cycles 1 to 6 in Phase IIDay 8, n=20,42207.4 Giga (10^9) cells per liter (G cells/L)Standard Deviation 110.93
21-Day Cycle Eltrombopag 100 mgMean Within-subject Platelet Count Prior to Scheduled Chemotherapy Across Cycles 1 to 6 in Phase IIDay 15, n=9,22106.7 Giga (10^9) cells per liter (G cells/L)Standard Deviation 54.73
Secondary

Number of Participants Requiring a Platelet Transfusion in Phase II

Platelet transfusion was used as a rescue medication for the treatment of thrombocytopenia. Number of participants requiring a platelet transfusion during Cycles 1-6 was summarized and compared between treatment groups using a logistic regression model adjusted for cycle duration. Each cycle included assessments starting at Day 1 of the cycle.

Time frame: Screening, Day -5, throughout cycles 1 to 6 and up to 30 days after IP discontinuation

Population: ITT Population

ArmMeasureGroupValue (NUMBER)
21-Day Cycle PlaceboNumber of Participants Requiring a Platelet Transfusion in Phase IICycle 10 Participants
21-Day Cycle PlaceboNumber of Participants Requiring a Platelet Transfusion in Phase IICycle 22 Participants
21-Day Cycle PlaceboNumber of Participants Requiring a Platelet Transfusion in Phase IICycle 30 Participants
21-Day Cycle PlaceboNumber of Participants Requiring a Platelet Transfusion in Phase IICycle 41 Participants
21-Day Cycle PlaceboNumber of Participants Requiring a Platelet Transfusion in Phase IICycle 50 Participants
21-Day Cycle PlaceboNumber of Participants Requiring a Platelet Transfusion in Phase IICycle 60 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants Requiring a Platelet Transfusion in Phase IICycle 50 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants Requiring a Platelet Transfusion in Phase IICycle 14 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants Requiring a Platelet Transfusion in Phase IICycle 41 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants Requiring a Platelet Transfusion in Phase IICycle 23 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants Requiring a Platelet Transfusion in Phase IICycle 60 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants Requiring a Platelet Transfusion in Phase IICycle 32 Participants
Secondary

Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase II

AE is any untoward medical occurrence temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a MP. For marketed MPs, this also includes failure to produce expected benefits, abuse, or misuse. SAE event is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect.

Time frame: From first dose of investigational product (IP) until 30 days after discontinuation of IP (Longer for AEs related to study participation)

Population: Safety Population

ArmMeasureGroupValue (NUMBER)
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIAny SAE Pre Therapy0 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IINeutopenia On-therapy+30 days13 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIAny SAE Post Therapy2 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIGastrointestinal disorders On-therapy+30 days12 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIAny SAE On Therapy+30 days12 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIBlood Creatinine increased On-therapy+30 days3 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIBlood/lymphatic system disorders On-therapy+30 day21 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIVascular discorders On-therapy+30 days2 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIAny AE On Therapy+30 days23 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IICardiac disorders On-therapy+30 days1 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIThrombocytopenia On-therapy+30 days11 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIPulmonary embolism On-therapy+30 days0 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIAny AE Post Therapy4 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIPortal vein thrombosis On-therapy+30 days1 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIAnemia On-therapy+30 days16 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIDeaths On-therapy+30 days9 Participants
21-Day Cycle PlaceboNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIAny AE Pre Therapy0 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIDeaths On-therapy+30 days13 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIAny AE Pre Therapy1 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIAny SAE Pre Therapy0 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIAny AE On Therapy+30 days48 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIAny SAE On Therapy+30 days16 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIAny AE Post Therapy2 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIAny SAE Post Therapy1 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIBlood/lymphatic system disorders On-therapy+30 day40 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIThrombocytopenia On-therapy+30 days19 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIAnemia On-therapy+30 days26 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IINeutopenia On-therapy+30 days21 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIGastrointestinal disorders On-therapy+30 days25 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIBlood Creatinine increased On-therapy+30 days2 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIVascular discorders On-therapy+30 days6 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IICardiac disorders On-therapy+30 days3 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIPulmonary embolism On-therapy+30 days1 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase IIPortal vein thrombosis On-therapy+30 days0 Participants
Secondary

Number of Participants With Any Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale, Across Cycles 1-6 in Phase II

The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0=no bleeding; Grade 1=petechiae; Grade 2=mild blood loss; Grade 3=gross bleeding; Grade 4=debilitating blood loss. The WHO grades were further classified into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. Baseline is defined as the Day 1 assessment or the latest possible screening assessment. Across Cycles 1-6 included all assessments after first dose of chemotherapy up to the end of Cycle 6. Data exclused for participants taking drugs that affect platelet function or anticoagulants, from the time that the medication was started.

Time frame: Screening, Day -5, Day 1 and 8 of Cycles 1 to 6 of 21-day cycle schedule, Day 1, 8 and 15 of cycles 1 to 6 of 28-day schedule, treatment withdrawal and 30-day follow-up

Population: ITT Population: Participants with at least one visit within the cycle.

ArmMeasureGroupValue (NUMBER)
21-Day Cycle PlaceboNumber of Participants With Any Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale, Across Cycles 1-6 in Phase IIGrade 11 Participants
21-Day Cycle PlaceboNumber of Participants With Any Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale, Across Cycles 1-6 in Phase IIGrade 30 Participants
21-Day Cycle PlaceboNumber of Participants With Any Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale, Across Cycles 1-6 in Phase IIGrade 20 Participants
21-Day Cycle PlaceboNumber of Participants With Any Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale, Across Cycles 1-6 in Phase IIGrade 40 Participants
21-Day Cycle PlaceboNumber of Participants With Any Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale, Across Cycles 1-6 in Phase IIGrade 011 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale, Across Cycles 1-6 in Phase IIGrade 41 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale, Across Cycles 1-6 in Phase IIGrade 034 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale, Across Cycles 1-6 in Phase IIGrade 10 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale, Across Cycles 1-6 in Phase IIGrade 20 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale, Across Cycles 1-6 in Phase IIGrade 30 Participants
Secondary

Number of Participants With Any Dose Reduction in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase II

Dose reductions are required following potential drug-related toxicities. Number of participants with any dose reduction during 21-day cycle or 28-day cycle, in part 1 or part 2 of the study is summarized and presented. Only participants who actually received chemotherapy were included for the cisplatin and carboplatin components. All participants were included for the gemcitabine components.

Time frame: Cycle 1 to Cycle 6

Population: ITT Population

ArmMeasureGroupValue (NUMBER)
21-Day Cycle PlaceboNumber of Participants With Any Dose Reduction in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase IICisplatin, 21-day cycle, n=7,90 Participants
21-Day Cycle PlaceboNumber of Participants With Any Dose Reduction in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase IICarboplatin, 21-day cycle, n=4,122 Participants
21-Day Cycle PlaceboNumber of Participants With Any Dose Reduction in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase IIGemcitabine, 28-day cycle, n=12,308 Participants
21-Day Cycle PlaceboNumber of Participants With Any Dose Reduction in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase IIGemcitabine, 21-day cycle, n=11,227 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Dose Reduction in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase IIGemcitabine, 28-day cycle, n=12,308 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Dose Reduction in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase IICarboplatin, 21-day cycle, n=4,122 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Dose Reduction in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase IICisplatin, 21-day cycle, n=7,93 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Any Dose Reduction in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase IIGemcitabine, 21-day cycle, n=11,226 Participants
Secondary

Number of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase I

Any delay in a scheduled dose of gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin was evaluated for eltrombopag and placebo treated participants.

Time frame: All time on chemotherapy treatment

Population: Safety Population

ArmMeasureValue (NUMBER)
21-Day Cycle PlaceboNumber of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase I1 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase I2 Participants
28-Day Cycle PlaceboNumber of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase I2 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase I1 Participants
Secondary

Number of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase II

Any delay in scheduled dose of gemcitabine monotherapy or the combination of gemcitabine plus carboplatin or cisplatin was evaluated for eltrombopag and placebo treated participants. Number of participants with any delay in dose during 21-day cycle or 28-day cycle, in part 1 or part 2 of the study is summarized and presented. Only those participants who actually received chemotherapy are included for the cisplatin and carboplatin components and all participants are included for the gemcitabine components (represented by n=X,X in the category titles).

Time frame: Cycle 1 to Cycle 6

Population: ITT Population

ArmMeasureGroupValue (NUMBER)
21-Day Cycle PlaceboNumber of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase IIGemcitabine, 21-day cycle, n=11,225 Participants
21-Day Cycle PlaceboNumber of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase IICarboplatin, 21-day cycle, n=4,124 Participants
21-Day Cycle PlaceboNumber of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase IICisplatin, 21-day cycle, n=7,91 Participants
21-Day Cycle PlaceboNumber of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase IIGemcitabine, 28-day cycle, n=12,304 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase IIGemcitabine, 28-day cycle, n=12,304 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase IIGemcitabine, 21-day cycle, n=11,227 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase IICisplatin, 21-day cycle, n=7,92 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With at Least One Delay in Their Scheduled Dose of Chemotherapy in Any Cycle in Phase IICarboplatin, 21-day cycle, n=4,125 Participants
Secondary

Number of Participants With Change From Baseline in Creatinine of >=26.5 UMOL/L in Phase II

Number of participants with at least 1 assessment of change from Baseline in creatinine, with increase \>=26.5 UMOL/L are presented. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of IP.

Time frame: After baseline (C1D1), on-treatment (collected on days 1 and 8 for subjects on 21-day cycle and on days 1, 8 and 15 for subjects on 28-day cycle) and 30 day follow-up

Population: Safety Population

ArmMeasureValue (NUMBER)
21-Day Cycle PlaceboNumber of Participants With Change From Baseline in Creatinine of >=26.5 UMOL/L in Phase II5 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Change From Baseline in Creatinine of >=26.5 UMOL/L in Phase II11 participants
Secondary

Number of Participants With Electrocardiogram (ECG) Findings at Cycle 1 Day 4 (2 to 6 Hours Post-dose) in Phase II

A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at screening and 2 to 6 hours post-dose on C1D4. Change in ECG findings were categorized as 'Clinically significant change (CSC): favorable', 'No change or insignificant change' or 'Clinically significant change (CSC): unfavorable' as determined by the investigator. The Baseline value is defined as the value reported immediately prior to the administration of the first dose of investigational product. Only those participants available at the indicated time points were analyzed (represented by n=X,X in the category titles).

Time frame: C1D4

Population: Safety Population

ArmMeasureGroupValue (NUMBER)
21-Day Cycle PlaceboNumber of Participants With Electrocardiogram (ECG) Findings at Cycle 1 Day 4 (2 to 6 Hours Post-dose) in Phase IICSC favorable, n=22,450 participants
21-Day Cycle PlaceboNumber of Participants With Electrocardiogram (ECG) Findings at Cycle 1 Day 4 (2 to 6 Hours Post-dose) in Phase IINo change or insignificant change, n=22,4520 participants
21-Day Cycle PlaceboNumber of Participants With Electrocardiogram (ECG) Findings at Cycle 1 Day 4 (2 to 6 Hours Post-dose) in Phase IICSC: unfavorable, n=22,452 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Electrocardiogram (ECG) Findings at Cycle 1 Day 4 (2 to 6 Hours Post-dose) in Phase IICSC favorable, n=22,452 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Electrocardiogram (ECG) Findings at Cycle 1 Day 4 (2 to 6 Hours Post-dose) in Phase IINo change or insignificant change, n=22,4542 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Electrocardiogram (ECG) Findings at Cycle 1 Day 4 (2 to 6 Hours Post-dose) in Phase IICSC: unfavorable, n=22,451 participants
Secondary

Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase II

Hematology parameters with a related NCI CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment, the maximum toxicity grade reached by a participant post-Baseline was summarized. Hematology parameters included Hemoglobin (Hb) increased, Anemia, Lymphocyte count (Lym), platelet count, White Blood Cell count (WBC) and Total Absolute Neutrophil Count (Total ANC). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. participants with missing Baseline value were assumed to have normal Baseline value. Only those Participant available at the indicated time points were analyzed (represented by n=X,X in the category titles).

Time frame: After baseline (C1D1), on-treatment and 30 day follow-up

Population: Safety Population

ArmMeasureGroupValue (NUMBER)
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIWBC count, Grade 4, n=23,522 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIHb (Increased), Grade 0, n=23,5223 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIHb (Increased), Grade 1, n=23,520 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIHb (Increased), Grade 2, n=23,520 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIHb (Increased), Grade 3, n=23,520 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIHb (Increased), Grade 4, n=23,520 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIHb (Anemia), Grade 0, n=23,520 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIHb (Anemia), Grade 1, n=23,524 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIHb (Anemia), Grade 2, n=23,5213 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIHb (Anemia), Grade 3, n=23,526 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIHb (Anemia), Grade 4, n=23,520 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IILym (Increased), Grade 0, n=23,5222 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IILym (Increased), Grade 1, n=23,520 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IILym (Increased), Grade 2, n=23,521 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IILym (Increased), Grade 3, n=23,520 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IILym (Increased), Grade 4, n=23,520 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IILym (Decreased), Grade 0, n=23,521 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IILym (Decreased), Grade 1, n=23,523 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IILym (Decreased), Grade 2, n=23,528 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IILym (Decreased), Grade 3, n=23,529 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IILym (Decreased), Grade 4, n=23,522 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IITotal ANC, Grade 0, n=23,524 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IITotal ANC, Grade 1, n=23,521 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IITotal ANC, Grade2, n=23,523 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IITotal ANC, Grade 3, n=23,5210 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IITotal ANC, Grade 4, n=23,525 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIPlatelet count, Grade 0, n=23,520 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIPlatelet count, Grade 1, n=23,524 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIPlatelet count, Grade 2, n=23,523 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIPlatelet count, Grade 3, n=23,526 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIPlatelet count, Grade 4, n=23,5210 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIWBC count, Grade 0, n=23,524 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIWBC count, Grade 1, n=23,523 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIWBC count, Grade 2, n=23,528 Participants
21-Day Cycle PlaceboNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIWBC count, Grade 3, n=23,526 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIWBC count, Grade 0, n=23,5214 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IILym (Decreased), Grade 2, n=23,5214 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIHb (Increased), Grade 0, n=23,5252 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIPlatelet count, Grade 1, n=23,529 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIHb (Increased), Grade 1, n=23,520 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IILym (Decreased), Grade 3, n=23,5216 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIHb (Increased), Grade 2, n=23,520 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIWBC count, Grade 4, n=23,520 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIHb (Increased), Grade 3, n=23,520 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IILym (Decreased), Grade 4, n=23,523 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIHb (Increased), Grade 4, n=23,520 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIPlatelet count, Grade 2, n=23,529 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIHb (Anemia), Grade 0, n=23,524 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IITotal ANC, Grade 0, n=23,5216 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIHb (Anemia), Grade 1, n=23,5216 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIWBC count, Grade 1, n=23,5210 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIHb (Anemia), Grade 2, n=23,5216 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IITotal ANC, Grade 1, n=23,524 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIHb (Anemia), Grade 3, n=23,5216 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIPlatelet count, Grade 3, n=23,5215 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIHb (Anemia), Grade 4, n=23,520 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IITotal ANC, Grade2, n=23,5217 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IILym (Increased), Grade 0, n=23,5247 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIWBC count, Grade 3, n=23,5211 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IILym (Increased), Grade 1, n=23,520 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IITotal ANC, Grade 3, n=23,5210 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IILym (Increased), Grade 2, n=23,522 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIPlatelet count, Grade 4, n=23,5212 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IILym (Increased), Grade 3, n=23,521 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IITotal ANC, Grade 4, n=23,523 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IILym (Increased), Grade 4, n=23,520 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIWBC count, Grade 2, n=23,5217 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IILym (Decreased), Grade 0, n=23,527 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IIPlatelet count, Grade 0, n=23,527 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase IILym (Decreased), Grade 1, n=23,5210 Participants
Secondary

Number of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase II

Clinical chemistry laboratory parameters with a related CTCAE (version 4.0) toxicity grading were summarized by toxicity grade at each scheduled assessment. Worst-case grade change of the laboratory parameters at anytime post-Baseline is presented as Any grade increase, Increase to Grade 3 or Grade 4. Clinical chemistry laboratory parameters included Albumin (Al), creatinine, AST, ALT, ALP, TB, Calcium hypercalcemia (CaHy)/hypocalcemia (CaHo), Glucose hyperglycemia (GluHy)/hypoglycemia (GluHo), Potassium hypernatremia (KHy)/hyponatremia (KHo) and Sodium hypernatremia (NaHy)/hyponatremia (NaHo). The Baseline value is defined as the value reported immediately prior to the administration of the first dose of chemotherapy in Cycle 1. Post-Baseline is defined as any time after the first dose of chemotherapy in Cycle 1 up to and including all follow-up visits. Only those Participant available at the indicated time points were analyzed (represented by n=X,X in the category titles).

Time frame: After baseline (C1D1), on-treatment (collected on days 1 and 8 for subjects on 21-day cycle and on days 1, 8 and 15 for subjects on 28-day cycle) and 30 day follow-up

Population: Safety Population

ArmMeasureGroupValue (NUMBER)
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIAST, Increase to Grade 3, n=23,523 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIAl, Increase to Grade 3, n=23,510 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIAl, Increase to Grade 4, n=23,510 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIALP, Any grade increase, n=23,5211 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIALP, Increase to Grade 3, n=23,521 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIALP, Increase to Grade 4, n=23,520 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIALT, Any grade increase, n=23,5212 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIALT, Increase to Grade 3, n=23,523 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIALT, Increase to Grade 4, n=23,520 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIAST, Any grade increase, n=23,5211 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIAl, Any grade increase, n=23,5110 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIAST, Increase to Grade 4, n=23,520 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IITB, Any grade increase, n=23,525 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IITB, Increase to Grade 3, n=23,523 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IITB, Increase to Grade 4, n=23,520 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IICaHy, Any grade increase, n=23,510 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IICaHy, Increase to Grade 3, n=23,510 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IICaHy, Increase to Grade 4, n=23,510 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IICaHo, Any grade increase, n=23,513 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IICaHo, Increase to Grade 3, n=23,511 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IICaHo, Increase to Grade 4, n=23,510 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IICreatinine, Any grade increase, n=23,525 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IICreatinine, Increase to Grade 3, n=23,521 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IICreatinine, Increase to Grade 4, n=23,520 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIGluHy, Any grade increase, n=23,5213 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIGluHy, Increase to Grade 3, n=23,522 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIGluHy, Increase to Grade 4, n=23,520 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIGluHo, Any grade increase, n=23,522 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIGluHo, Increase to Grade 3, n=23,520 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIGluHo, Increase to Grade 4, n=23,521 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IINaHy, Any grade increase, n=23,520 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IINaHy, Increase to Grade 3, n=23,520 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IINaHy, Increase to Grade 4, n=23,520 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IINaHo, Any grade increase, n=23,524 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IINaHo, Increase to Grade 3, n=23,521 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IINaHo, Increase to Grade 4, n=23,520 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIKHy, Any grade increase, n=23,524 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIKHy, Increase to Grade 3, n=23,521 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIKHy, Increase to Grade 4, n=23,520 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIKHo, Any grade increase, n=23,525 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIKHo, Increase to Grade 3, n=23,521 participants
21-Day Cycle PlaceboNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIKHo, Increase to Grade 4, n=23,520 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IINaHy, Increase to Grade 3, n=23,520 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIAl, Any grade increase, n=23,5122 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IICreatinine, Any grade increase, n=23,5211 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIAl, Increase to Grade 3, n=23,512 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIKHo, Any grade increase, n=23,5211 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIAl, Increase to Grade 4, n=23,510 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IICreatinine, Increase to Grade 3, n=23,520 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIALP, Any grade increase, n=23,5216 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IINaHy, Increase to Grade 4, n=23,520 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIALP, Increase to Grade 3, n=23,522 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IICreatinine, Increase to Grade 4, n=23,520 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIALP, Increase to Grade 4, n=23,520 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIKHy, Increase to Grade 3, n=23,521 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIALT, Any grade increase, n=23,5216 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIGluHy, Any grade increase, n=23,5231 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIALT, Increase to Grade 3, n=23,522 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IINaHo, Any grade increase, n=23,5215 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIALT, Increase to Grade 4, n=23,520 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIGluHy, Increase to Grade 3, n=23,523 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIAST, Any grade increase, n=23,5215 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIKHo, Increase to Grade 4, n=23,521 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIAST, Increase to Grade 3, n=23,522 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIGluHy, Increase to Grade 4, n=23,520 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIAST, Increase to Grade 4, n=23,520 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IINaHo, Increase to Grade 3, n=23,521 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IITB, Any grade increase, n=23,5211 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIGluHo, Any grade increase, n=23,524 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IITB, Increase to Grade 3, n=23,522 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIKHy, Increase to Grade 4, n=23,520 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IITB, Increase to Grade 4, n=23,520 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIGluHo, Increase to Grade 3, n=23,520 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IICaHy, Any grade increase, n=23,511 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IINaHo, Increase to Grade 4, n=23,520 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IICaHy, Increase to Grade 3, n=23,510 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIGluHo, Increase to Grade 4, n=23,520 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IICaHy, Increase to Grade 4, n=23,510 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIKHo, Increase to Grade 3, n=23,524 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IICaHo, Any grade increase, n=23,5110 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IINaHy, Any grade increase, n=23,522 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IICaHo, Increase to Grade 3, n=23,512 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IIKHy, Any grade increase, n=23,5210 participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Indicated Worst-case Change From Baseline in Clinical Chemistry Laboratory Parameters Using CTCAE Toxicity Grading, at Anytime Post-Baseline in Phase IICaHo, Increase to Grade 4, n=23,510 participants
Secondary

Number of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet Count

As per the CTCAE version 4.0, par. with a platelet count \<LLN but \>=75 x 10\^9/L (Gi/L) were considered to have Grade 1 thrombocytopenia; par. with a platelet count \<75Gi/L, but \>=50Gi/L were considered to have Grade 2 thrombocytopenia; par. with a platelet count \<50Gi/L, but \>=25Gi/L were considered to have Grade 3 thrombocytopenia and par. with a platelet count \<25Gi/L were considered to have Grade 4 thrombocytopenia. Blood samples were collected to estimate thrombocytes at the following time points: For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate thrombocytes at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Par. experiencing thrombocytopenia (Platelets \<150Gi/L) at least once within a cycle are presented in the category title as n=X,X,X,X.

Time frame: Cycle 1 to Cycle 6

Population: Safety Population

ArmMeasureGroupValue (NUMBER)
21-Day Cycle PlaceboNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet CountGrade 4, n=3,9,4,101 Participants
21-Day Cycle PlaceboNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet CountGrade 2, n=3,9,4,100 Participants
21-Day Cycle PlaceboNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet CountGrade 0 / None, n=3,9,4,101 Participants
21-Day Cycle PlaceboNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet CountGrade 3, n=3,9,4,101 Participants
21-Day Cycle PlaceboNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet CountGrade 1, n=3,9,4,100 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet CountGrade 3, n=3,9,4,101 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet CountGrade 4, n=3,9,4,102 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet CountGrade 0 / None, n=3,9,4,101 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet CountGrade 2, n=3,9,4,103 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet CountGrade 1, n=3,9,4,102 Participants
28-Day Cycle PlaceboNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet CountGrade 3, n=3,9,4,101 Participants
28-Day Cycle PlaceboNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet CountGrade 1, n=3,9,4,101 Participants
28-Day Cycle PlaceboNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet CountGrade 2, n=3,9,4,101 Participants
28-Day Cycle PlaceboNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet CountGrade 4, n=3,9,4,100 Participants
28-Day Cycle PlaceboNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet CountGrade 0 / None, n=3,9,4,101 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet CountGrade 4, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet CountGrade 2, n=3,9,4,104 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet CountGrade 1, n=3,9,4,103 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet CountGrade 3, n=3,9,4,100 Participants
28-Day Cycle Eltrombopag 100 mgNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across All the Chemotherapy Cycles in Phase I, Using Central Laboratory Platelet CountGrade 0 / None, n=3,9,4,103 Participants
Secondary

Number of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across Cycles 1 to 6 in Phase II

As per the CTCAE version 4.0, participants with a platelet count \<LLN but \>=75 x 10\^9/L (Gi/L) were considered to have Grade 1 thrombocytopenia; participants with a platelet count \<75Gi/L, but \>=50Gi/L were considered to have Grade 2 thrombocytopenia; participants with a platelet count \<50Gi/L, but \>=25Gi/L were considered to have Grade 3 thrombocytopenia and participants with a platelet count \<25Gi/L were considered to have Grade 4 thrombocytopenia. Blood samples were collected to estimate thrombocytes at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Participants experiencing thrombocytopenia(Platelets \<150Gi/L) at least once within cycle are presented in the category title as n=X,X.

Time frame: Cycle 1 to Cycle 6

Population: ITT Population

ArmMeasureGroupValue (NUMBER)
21-Day Cycle PlaceboNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across Cycles 1 to 6 in Phase IIGrade 23 Participants
21-Day Cycle PlaceboNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across Cycles 1 to 6 in Phase IIGrade 48 Participants
21-Day Cycle PlaceboNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across Cycles 1 to 6 in Phase IIGrade 38 Participants
21-Day Cycle PlaceboNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across Cycles 1 to 6 in Phase IINone0 Participants
21-Day Cycle PlaceboNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across Cycles 1 to 6 in Phase IIGrade 14 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across Cycles 1 to 6 in Phase IINone5 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across Cycles 1 to 6 in Phase IIGrade 19 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across Cycles 1 to 6 in Phase IIGrade 29 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across Cycles 1 to 6 in Phase IIGrade 315 Participants
21-Day Cycle Eltrombopag 100 mgNumber of Participants With Thrombocytopenia of Grade 1, 2, 3 or 4 Across Cycles 1 to 6 in Phase IIGrade 412 Participants
Secondary

Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase II

ECOG-Zubrod scores for the Performance Status were defined as follows: 0: Fully active, 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2: Ambulatory and capable of all self-care but unable to carry out any work activities, 3: Capable of only limited self-care, 4: Completely disabled, 5 and Unknown: Dead. The data is presented for the participants with the ECOG performance score at different time points during the study. Only those participants available at the indicated time points were analyzed (represented by n=X,X in the category titles).

Time frame: Screening, C1D1, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1 and C17D1

Population: Safety Population

ArmMeasureGroupValue (NUMBER)
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIScreening, Score 0, n=23,523 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIScreening, Score 1, n=23,5219 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIScreening, Score 2, n=23,521 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC1D1, Score 0, n=23,494 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC1D1, Score 1, n=23,4917 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC1D1, Score 2, n=23,490 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC1D1, Unknown, n=23,492 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC2D1, Score 0, n=19,364 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC2D1, Score 1, n=19,3613 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC2D1, Score 2, n=19,362 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC3D1, Score 0, n=13,273 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC3D1, Score 1, n=13,279 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC3D1, Score 2, n=13,271 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC4D1, Score 0, n=11,194 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC4D1, Score 1, n=11,197 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC4D1, Score 2, n=11,190 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC5D1, Score 0, n=6,122 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC5D1, Score 1, n=6,124 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC5D1, Score 2, n=6,120 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC6D1, Score 0, n=6,72 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC6D1, Score 1, n=6,74 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC7D1, Score 0, n=3,21 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC7D1, Score 1, n=3,22 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC8D1, Score 0, n=2,11 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC8D1, Score 1, n=2,11 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC9D1, Score 1, n=2,12 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC10D1, Score1 n=2,02 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC11D1, Score 1, n=2,01 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC11D1, Score 2, n=2,01 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC12D1, Score 1, n=2,02 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC13D1, Score 0, n=2,01 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC13D1, Score 1, n=2,01 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC14D1, Score 0, n=2,01 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC14D1, Score 1, n=2,01 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC15D1, Score 1, n=2,02 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC16D1, Score 0, n=1,01 participants
21-Day Cycle PlaceboNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC17D1, Score 2, n=1,01 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC5D1, Score 2, n=6,121 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIScreening, Score 0, n=23,5219 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC14D1, Score 0, n=2,00 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIScreening, Score 1, n=23,5232 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC6D1, Score 0, n=6,73 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIScreening, Score 2, n=23,521 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC11D1, Score 2, n=2,00 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC1D1, Score 0, n=23,4920 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC6D1, Score 1, n=6,74 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC1D1, Score 1, n=23,4928 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC17D1, Score 2, n=1,00 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC1D1, Score 2, n=23,491 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC7D1, Score 0, n=3,20 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC1D1, Unknown, n=23,490 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC12D1, Score 1, n=2,00 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC2D1, Score 0, n=19,3616 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC7D1, Score 1, n=3,22 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC2D1, Score 1, n=19,3618 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC14D1, Score 1, n=2,00 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC2D1, Score 2, n=19,362 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC8D1, Score 0, n=2,10 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC3D1, Score 0, n=13,279 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC13D1, Score 0, n=2,00 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC3D1, Score 1, n=13,2716 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC8D1, Score 1, n=2,11 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC3D1, Score 2, n=13,272 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC16D1, Score 0, n=1,00 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC4D1, Score 0, n=11,198 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC9D1, Score 1, n=2,11 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC4D1, Score 1, n=11,1910 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC13D1, Score 1, n=2,00 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC4D1, Score 2, n=11,191 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC10D1, Score1 n=2,00 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC5D1, Score 0, n=6,125 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC15D1, Score 1, n=2,00 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC5D1, Score 1, n=6,126 participants
21-Day Cycle Eltrombopag 100 mgNumber of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase IIC11D1, Score 1, n=2,00 participants
Secondary

Platelet Count Nadir for Each Chemotherapy Cycle in Phase I

Platelet nadir is defined as the lowest platelet count (from central laboratory data) reported after the first dose of chemotherapy within each cycle. Platelet count nadir is defined for each cycle. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet nadir count at the following time points: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 and 2, at Days 1, 4, 8, 15 and 17 of Cycle 3 to 6. Group B; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).

Time frame: Cycle 1 to Cycle 6

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
21-Day Cycle PlaceboPlatelet Count Nadir for Each Chemotherapy Cycle in Phase ICycle 1, n=3,9,4,1030.67 Giga (10^9) cells per liter (G cells/L)Standard Deviation 20.404
21-Day Cycle PlaceboPlatelet Count Nadir for Each Chemotherapy Cycle in Phase ICycle 2, n=2,9,4,1066.00 Giga (10^9) cells per liter (G cells/L)Standard Deviation 9.899
21-Day Cycle PlaceboPlatelet Count Nadir for Each Chemotherapy Cycle in Phase ICycle 3, n=2,7,2,747.00 Giga (10^9) cells per liter (G cells/L)Standard Deviation 4.243
21-Day Cycle PlaceboPlatelet Count Nadir for Each Chemotherapy Cycle in Phase ICycle 4, n=2,6,1,776.50 Giga (10^9) cells per liter (G cells/L)Standard Deviation 4.95
21-Day Cycle PlaceboPlatelet Count Nadir for Each Chemotherapy Cycle in Phase ICycle 5, n=1,2,1,414.00 Giga (10^9) cells per liter (G cells/L)
21-Day Cycle PlaceboPlatelet Count Nadir for Each Chemotherapy Cycle in Phase ICycle 6, n=1,1,1,424.00 Giga (10^9) cells per liter (G cells/L)
21-Day Cycle Eltrombopag 100 mgPlatelet Count Nadir for Each Chemotherapy Cycle in Phase ICycle 6, n=1,1,1,413.00 Giga (10^9) cells per liter (G cells/L)
21-Day Cycle Eltrombopag 100 mgPlatelet Count Nadir for Each Chemotherapy Cycle in Phase ICycle 4, n=2,6,1,787.50 Giga (10^9) cells per liter (G cells/L)Standard Deviation 79.173
21-Day Cycle Eltrombopag 100 mgPlatelet Count Nadir for Each Chemotherapy Cycle in Phase ICycle 1, n=3,9,4,10106.56 Giga (10^9) cells per liter (G cells/L)Standard Deviation 113.338
21-Day Cycle Eltrombopag 100 mgPlatelet Count Nadir for Each Chemotherapy Cycle in Phase ICycle 3, n=2,7,2,788.29 Giga (10^9) cells per liter (G cells/L)Standard Deviation 71.807
21-Day Cycle Eltrombopag 100 mgPlatelet Count Nadir for Each Chemotherapy Cycle in Phase ICycle 2, n=2,9,4,10122.44 Giga (10^9) cells per liter (G cells/L)Standard Deviation 115.794
21-Day Cycle Eltrombopag 100 mgPlatelet Count Nadir for Each Chemotherapy Cycle in Phase ICycle 5, n=1,2,1,4148.00 Giga (10^9) cells per liter (G cells/L)Standard Deviation 182.434
28-Day Cycle PlaceboPlatelet Count Nadir for Each Chemotherapy Cycle in Phase ICycle 2, n=2,9,4,10103.50 Giga (10^9) cells per liter (G cells/L)Standard Deviation 62.952
28-Day Cycle PlaceboPlatelet Count Nadir for Each Chemotherapy Cycle in Phase ICycle 3, n=2,7,2,778.50 Giga (10^9) cells per liter (G cells/L)Standard Deviation 43.134
28-Day Cycle PlaceboPlatelet Count Nadir for Each Chemotherapy Cycle in Phase ICycle 4, n=2,6,1,786.00 Giga (10^9) cells per liter (G cells/L)
28-Day Cycle PlaceboPlatelet Count Nadir for Each Chemotherapy Cycle in Phase ICycle 6, n=1,1,1,4110.00 Giga (10^9) cells per liter (G cells/L)
28-Day Cycle PlaceboPlatelet Count Nadir for Each Chemotherapy Cycle in Phase ICycle 5, n=1,2,1,475.00 Giga (10^9) cells per liter (G cells/L)
28-Day Cycle PlaceboPlatelet Count Nadir for Each Chemotherapy Cycle in Phase ICycle 1, n=3,9,4,1060.50 Giga (10^9) cells per liter (G cells/L)Standard Deviation 22.664
28-Day Cycle Eltrombopag 100 mgPlatelet Count Nadir for Each Chemotherapy Cycle in Phase ICycle 5, n=1,2,1,4113.25 Giga (10^9) cells per liter (G cells/L)Standard Deviation 34.683
28-Day Cycle Eltrombopag 100 mgPlatelet Count Nadir for Each Chemotherapy Cycle in Phase ICycle 6, n=1,1,1,4122.75 Giga (10^9) cells per liter (G cells/L)Standard Deviation 63.163
28-Day Cycle Eltrombopag 100 mgPlatelet Count Nadir for Each Chemotherapy Cycle in Phase ICycle 2, n=2,9,4,10135.50 Giga (10^9) cells per liter (G cells/L)Standard Deviation 73.951
28-Day Cycle Eltrombopag 100 mgPlatelet Count Nadir for Each Chemotherapy Cycle in Phase ICycle 4, n=2,6,1,7142.86 Giga (10^9) cells per liter (G cells/L)Standard Deviation 91.908
28-Day Cycle Eltrombopag 100 mgPlatelet Count Nadir for Each Chemotherapy Cycle in Phase ICycle 1, n=3,9,4,1099.00 Giga (10^9) cells per liter (G cells/L)Standard Deviation 75.7
28-Day Cycle Eltrombopag 100 mgPlatelet Count Nadir for Each Chemotherapy Cycle in Phase ICycle 3, n=2,7,2,7151.00 Giga (10^9) cells per liter (G cells/L)Standard Deviation 111.946
Secondary

Platelet Count Nadir for Each Chemotherapy Cycle in Phase II

Platelet nadir is defined as the lowest platelet count reported after the first dose of chemotherapy within each cycle. Platelet count nadir is defined for each cycle. Blood samples were collected to estimate platelet nadir count at the following time points: 21-day cycle; Day 1, Day 4, Day 8, Day 15 and Day 17 of Cycles 1 to 6. 28-day cycle; Day 1, Day 4, Day 8, Day 15, Day 22, Day 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X).

Time frame: Cycle 1 to Cycle 6

Population: ITT Population

ArmMeasureGroupValue (MEAN)Dispersion
21-Day Cycle PlaceboPlatelet Count Nadir for Each Chemotherapy Cycle in Phase IICycle 1, n=23,4868.3 Giga (10^9) cells per liter (G cells/L)Standard Deviation 47.74
21-Day Cycle PlaceboPlatelet Count Nadir for Each Chemotherapy Cycle in Phase IICycle 2, n=19,3761.5 Giga (10^9) cells per liter (G cells/L)Standard Deviation 35.82
21-Day Cycle PlaceboPlatelet Count Nadir for Each Chemotherapy Cycle in Phase IICycle 3, n=13,2671.6 Giga (10^9) cells per liter (G cells/L)Standard Deviation 53.8
21-Day Cycle PlaceboPlatelet Count Nadir for Each Chemotherapy Cycle in Phase IICycle 4, n=11, 1989.7 Giga (10^9) cells per liter (G cells/L)Standard Deviation 116.73
21-Day Cycle PlaceboPlatelet Count Nadir for Each Chemotherapy Cycle in Phase IICycle 5, n=6,1151.7 Giga (10^9) cells per liter (G cells/L)Standard Deviation 12.23
21-Day Cycle PlaceboPlatelet Count Nadir for Each Chemotherapy Cycle in Phase IICycle 6, n=5,569.6 Giga (10^9) cells per liter (G cells/L)Standard Deviation 62.76
21-Day Cycle Eltrombopag 100 mgPlatelet Count Nadir for Each Chemotherapy Cycle in Phase IICycle 5, n=6,1183.0 Giga (10^9) cells per liter (G cells/L)Standard Deviation 58.63
21-Day Cycle Eltrombopag 100 mgPlatelet Count Nadir for Each Chemotherapy Cycle in Phase IICycle 1, n=23,4877.2 Giga (10^9) cells per liter (G cells/L)Standard Deviation 76.43
21-Day Cycle Eltrombopag 100 mgPlatelet Count Nadir for Each Chemotherapy Cycle in Phase IICycle 4, n=11, 1986.9 Giga (10^9) cells per liter (G cells/L)Standard Deviation 56.11
21-Day Cycle Eltrombopag 100 mgPlatelet Count Nadir for Each Chemotherapy Cycle in Phase IICycle 2, n=19,3768.5 Giga (10^9) cells per liter (G cells/L)Standard Deviation 48.92
21-Day Cycle Eltrombopag 100 mgPlatelet Count Nadir for Each Chemotherapy Cycle in Phase IICycle 6, n=5,5136.6 Giga (10^9) cells per liter (G cells/L)Standard Deviation 151.88
21-Day Cycle Eltrombopag 100 mgPlatelet Count Nadir for Each Chemotherapy Cycle in Phase IICycle 3, n=13,2684.7 Giga (10^9) cells per liter (G cells/L)Standard Deviation 60.03
Secondary

Time Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase II

Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. The time taken to reach platelet nadir is defined within each cycle. Blood samples were collected to estimate platelet nadir count at the following time points: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22 and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X).

Time frame: Cycle 1 to Cycle 6

Population: ITT Population

ArmMeasureGroupValue (MEAN)Dispersion
21-Day Cycle PlaceboTime Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase IICycle 5, n=6,1115.5 DaysStandard Deviation 6.38
21-Day Cycle PlaceboTime Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase IICycle 3, n=13,2615.8 DaysStandard Deviation 5.64
21-Day Cycle PlaceboTime Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase IICycle 6, n=5,513.6 DaysStandard Deviation 7.37
21-Day Cycle PlaceboTime Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase IICycle 2, n=19,3715.1 DaysStandard Deviation 4.41
21-Day Cycle PlaceboTime Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase IICycle 7,n=2,215.0 DaysStandard Deviation 0
21-Day Cycle PlaceboTime Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase IICycle 8, n=2,112.5 DaysStandard Deviation 3.54
21-Day Cycle PlaceboTime Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase IICycle 4, n=11,1915.4 DaysStandard Deviation 5.48
21-Day Cycle PlaceboTime Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase IICycle 9, n=2,012.5 DaysStandard Deviation 3.54
21-Day Cycle PlaceboTime Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase IICycle 1, n=23,4814.7 DaysStandard Deviation 4.85
21-Day Cycle Eltrombopag 100 mgTime Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase IICycle 9, n=2,0NA Days
21-Day Cycle Eltrombopag 100 mgTime Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase IICycle 1, n=23,4815.7 DaysStandard Deviation 6.12
21-Day Cycle Eltrombopag 100 mgTime Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase IICycle 2, n=19,3715.4 DaysStandard Deviation 3.62
21-Day Cycle Eltrombopag 100 mgTime Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase IICycle 3, n=13,2614.3 DaysStandard Deviation 4.76
21-Day Cycle Eltrombopag 100 mgTime Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase IICycle 4, n=11,1914.7 DaysStandard Deviation 5.19
21-Day Cycle Eltrombopag 100 mgTime Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase IICycle 5, n=6,1113.8 DaysStandard Deviation 4.45
21-Day Cycle Eltrombopag 100 mgTime Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase IICycle 6, n=5,510.4 DaysStandard Deviation 6.31
21-Day Cycle Eltrombopag 100 mgTime Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase IICycle 8, n=2,18.0 Days
21-Day Cycle Eltrombopag 100 mgTime Taken to Reach Platelet Nadir for Each Chemotherapy Cycle in Phase IICycle 7,n=2,27.5 DaysStandard Deviation 0.71
Secondary

Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet Counts

Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. Time to recovery (TR) (\>100Gi/L or \>150Gi/L) from platelet nadir is defined within each cycle as the time in days from the platelet nadir to the time at which platelet count returns to \>=100Gi/L or \>=150Gi/L within the same cycle or up to and including Day 1 of the next cycle. For the last cycle in the study, time to recovery was calculated in the same manner but up to and including any Conclusion/Early Withdrawal visit which has been assigned to the same cycle. For Group A, the chemotherapy cycle consisted of 21 days and for Group B, the chemotherapy cycle consisted of 28 days. Blood samples were collected to estimate platelet count at: Group A; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. Group B; Days 1, 4, 8, 15, 22, and 24 of Cycles 1 to 6. Only those participants available at indicated time points were analyzed (represented by n=X, X, X, X).

Time frame: Cycle 1 to Cycle 6

Population: Safety Population

ArmMeasureGroupValue (MEAN)Dispersion
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<150Gi/L to >=150Gi/L), Cycle 4, n=1,4,1,48.0 Days
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<150Gi/L to >=150Gi/L), Cycle 6, n=0,0,1,0NA Days
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<150Gi/L to >=150Gi/L), Cycle 2, n=2,4,3,56.5 DaysStandard Deviation 2.12
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<100Gi/L to >=100Gi/L), Cycle 1, n=3,6,4,75.3 DaysStandard Deviation 0.58
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<150Gi/L to >=150Gi/L), Cycle 3, n=1,6,1,57.0 Days
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<100Gi/L to >=100Gi/L), Cycle 3, n=1,4,0,27.0 Days
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<100Gi/L to >=100Gi/L), Cycle 4, n=1,4,1,22.0 Days
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<100Gi/L to >=100Gi/L), Cycle 2, n=2,5,3,46.5 DaysStandard Deviation 2.12
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<150Gi/L to >=150Gi/L), Cycle 5, n=1,0,1,35.0 Days
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<100Gi/L to >=100Gi/L), Cycle 5, n=1,1,1,15.0 Days
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<100Gi/L to >=100Gi/L), Cycle 6, n=0,1,0,0NA Days
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<150Gi/L to >=150Gi/L), Cycle 1, n=3,7,4,85.3 DaysStandard Deviation 0.58
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<100Gi/L to >=100Gi/L), Cycle 2, n=2,5,3,46.6 DaysStandard Deviation 3.65
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<150Gi/L to >=150Gi/L), Cycle 1, n=3,7,4,87.6 DaysStandard Deviation 2.57
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<100Gi/L to >=100Gi/L), Cycle 4, n=1,4,1,26.5 DaysStandard Deviation 5.2
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<150Gi/L to >=150Gi/L), Cycle 3, n=1,6,1,58.0 DaysStandard Deviation 2.97
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<150Gi/L to >=150Gi/L), Cycle 4, n=1,4,1,47.8 DaysStandard Deviation 4.27
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<150Gi/L to >=150Gi/L), Cycle 2, n=2,4,3,57.8 DaysStandard Deviation 2.99
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<100Gi/L to >=100Gi/L), Cycle 1, n=3,6,4,77.2 DaysStandard Deviation 2.56
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<100Gi/L to >=100Gi/L), Cycle 6, n=0,1,0,07.0 Days
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<100Gi/L to >=100Gi/L), Cycle 5, n=1,1,1,15.0 Days
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<100Gi/L to >=100Gi/L), Cycle 3, n=1,4,0,28.5 DaysStandard Deviation 3.7
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<150Gi/L to >=150Gi/L), Cycle 6, n=0,0,1,0NA Days
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<150Gi/L to >=150Gi/L), Cycle 5, n=1,0,1,3NA Days
28-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<150Gi/L to >=150Gi/L), Cycle 2, n=2,4,3,59.0 DaysStandard Deviation 4.36
28-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<100Gi/L to >=100Gi/L), Cycle 1, n=3,6,4,77.0 DaysStandard Deviation 0
28-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<100Gi/L to >=100Gi/L), Cycle 2, n=2,5,3,46.0 DaysStandard Deviation 4
28-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<100Gi/L to >=100Gi/L), Cycle 3, n=1,4,0,2NA Days
28-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<100Gi/L to >=100Gi/L), Cycle 4, n=1,4,1,214.0 Days
28-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<100Gi/L to >=100Gi/L), Cycle 5, n=1,1,1,19.0 Days
28-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<100Gi/L to >=100Gi/L), Cycle 6, n=0,1,0,0NA Days
28-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<150Gi/L to >=150Gi/L), Cycle 1, n=3,7,4,87.0 DaysStandard Deviation 0
28-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<150Gi/L to >=150Gi/L), Cycle 3, n=1,6,1,57.0 Days
28-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<150Gi/L to >=150Gi/L), Cycle 4, n=1,4,1,414.0 Days
28-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<150Gi/L to >=150Gi/L), Cycle 5, n=1,0,1,314.0 Days
28-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<150Gi/L to >=150Gi/L), Cycle 6, n=0,0,1,05.0 Days
28-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<100Gi/L to >=100Gi/L), Cycle 6, n=0,1,0,0NA Days
28-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<100Gi/L to >=100Gi/L), Cycle 5, n=1,1,1,17.0 Days
28-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<100Gi/L to >=100Gi/L), Cycle 1, n=3,6,4,77.7 DaysStandard Deviation 2.87
28-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<150Gi/L to >=150Gi/L), Cycle 4, n=1,4,1,48.3 DaysStandard Deviation 3.95
28-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<100Gi/L to >=100Gi/L), Cycle 4, n=1,4,1,25.0 DaysStandard Deviation 2.83
28-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<100Gi/L to >=100Gi/L), Cycle 3, n=1,4,0,26.0 DaysStandard Deviation 1.41
28-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<150Gi/L to >=150Gi/L), Cycle 6, n=0,0,1,0NA Days
28-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<150Gi/L to >=150Gi/L), Cycle 5, n=1,0,1,34.7 DaysStandard Deviation 2.52
28-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<150Gi/L to >=150Gi/L), Cycle 2, n=2,4,3,59.4 DaysStandard Deviation 4.28
28-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<150Gi/L to >=150Gi/L), Cycle 1, n=3,7,4,88.5 DaysStandard Deviation 3.46
28-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<100Gi/L to >=100Gi/L), Cycle 2, n=2,5,3,47.0 DaysStandard Deviation 5.1
28-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase I, Estimated Using Central Laboratory Platelet CountsTR(<150Gi/L to >=150Gi/L), Cycle 3, n=1,6,1,56.2 DaysStandard Deviation 1.1
Secondary

Time to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase II

Platelet nadir is defined within each cycle as the lowest platelet count reported after the Day 1 chemotherapy dose. TR (\>100Gi/L or \>150Gi/L) from platelet nadir is defined within each cycle as the time in days from the platelet nadir to the time at which platelet count returns to \>=100Gi/L or \>=150Gi/L within the same cycle or up to and including Day 1 of the next cycle. For the last cycle in the study, time to recovery was calculated in the same manner but up to and including any Conclusion/Early Withdrawal visit which has been assigned to the same cycle. Blood samples were collected to estimate platelet count at: 21-day cycle; Days 1, 4, 8, 15 and 17 of Cycles 1 to 6. 28-day cycle; Days 1, 4, 8, 15, 22, and 24of Cycles 1 to 6. Time to recover censored if platelet count did not return to \>=100/150 Gi/L. Censored results are excluded from calculation of summary statistics. Only those participants available at indicated time points were analyzed (represented by n=X, X).

Time frame: Cycle 1 to Cycle 6

Population: ITT Population

ArmMeasureGroupValue (MEAN)Dispersion
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<100Gi/L to >=100Gi/L), Cycle 1, n=17, 328.1 DaysStandard Deviation 3.15
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<150Gi/L to >=150Gi/L), Cycle 1, n=12, 299.3 DaysStandard Deviation 3.89
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<100Gi/L to >=100Gi/L), Cycle 2, n=13, 249.9 DaysStandard Deviation 3.64
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<150Gi/L to >=150Gi/L), Cycle 2, n=11, 2110.5 DaysStandard Deviation 4.5
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<100Gi/L to >=100Gi/L), Cycle 3, n=9, 1210.1 DaysStandard Deviation 5.01
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<150Gi/L to >=150Gi/L), Cycle 3, n=7, 1410.4 DaysStandard Deviation 5.74
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<100Gi/L to >=100Gi/L), Cycle 4, n=8, 1010.0 DaysStandard Deviation 5.63
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<150Gi/L to >=150Gi/L), Cycle 4, n=5, 1110.2 DaysStandard Deviation 6.65
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<100Gi/L to >=100Gi/L), Cycle 5, n=5,67.8 DaysStandard Deviation 1.1
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<150Gi/L to >=150Gi/L), Cycle 5, n=2,48.0 DaysStandard Deviation 0
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<100Gi/L to >=100Gi/L), Cycle 6, n=2,210.5 DaysStandard Deviation 6.36
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<150Gi/L to >=150Gi/L), Cycle 6, n=2,110.5 DaysStandard Deviation 6.36
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<100Gi/L to >=100Gi/L), Cycle 7, n=1,115.0 Days
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<150Gi/L to >=150Gi/L), Cycle 7, n=1,115.0 Days
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<100Gi/L to >=100Gi/L), Cycle 8, n=1,114.0 DaysStandard Deviation 1.41
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<150Gi/L to >=150Gi/L), Cycle 8, n=1,015.0 Days
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<100Gi/L to >=100Gi/L), Cycle 9, n=2,14.0 DaysStandard Deviation 11.31
21-Day Cycle PlaceboTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<150Gi/L to >=150Gi/L), Cycle 9, n=0,NA Days
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<150Gi/L to >=150Gi/L), Cycle 7, n=1,122.0 Days
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<100Gi/L to >=100Gi/L), Cycle 1, n=17, 328.5 DaysStandard Deviation 3.7
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<150Gi/L to >=150Gi/L), Cycle 5, n=2,47.3 DaysStandard Deviation 1.5
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<150Gi/L to >=150Gi/L), Cycle 1, n=12, 299.1 DaysStandard Deviation 3.26
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<150Gi/L to >=150Gi/L), Cycle 9, n=0,NA Days
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<100Gi/L to >=100Gi/L), Cycle 2, n=13, 248.3 DaysStandard Deviation 2.56
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<100Gi/L to >=100Gi/L), Cycle 6, n=2,28.5 DaysStandard Deviation 0.71
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<150Gi/L to >=150Gi/L), Cycle 2, n=11, 219.0 DaysStandard Deviation 3.31
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<100Gi/L to >=100Gi/L), Cycle 8, n=1,120.0 Days
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<100Gi/L to >=100Gi/L), Cycle 3, n=9, 128.8 DaysStandard Deviation 3.16
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<150Gi/L to >=150Gi/L), Cycle 6, n=2,18.0 Days
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<150Gi/L to >=150Gi/L), Cycle 3, n=7, 149.6 DaysStandard Deviation 3.43
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<100Gi/L to >=100Gi/L), Cycle 9, n=2,NA Days
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<100Gi/L to >=100Gi/L), Cycle 4, n=8, 1010.9 DaysStandard Deviation 4.77
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<100Gi/L to >=100Gi/L), Cycle 7, n=1,122.0 Days
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<150Gi/L to >=150Gi/L), Cycle 4, n=5, 1110.6 DaysStandard Deviation 5.39
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<150Gi/L to >=150Gi/L), Cycle 8, n=1,0NA Days
21-Day Cycle Eltrombopag 100 mgTime to Recovery From Platelet Nadir for Each Chemotherapy Cycle in Phase IITR(<100Gi/L to >=100Gi/L), Cycle 5, n=5,68.8 DaysStandard Deviation 4.79

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026